Index: General Notices (1) Apply To All Monographs and Other Texts

EUROPEAN PHARMACOPOEIA 10.
0 Index
1. General notices......................................................................... 3 2.2.66. Detection and measurement of radioactivity ........... 119

2.1. Apparatus ............................................................................. 15 2.2.7. Optical rotation ................................................................ 26
2.1.1. Droppers ........................................................................... 15 2.2.8. Viscosity ............................................................................ 27
2.1.2. Comparative table of porosity of sintered-glass filters.. 15 2.2.9. Capillary viscometer method ......................................... 27
2.1.3. Ultraviolet ray lamps for analytical purposes............... 15 2.3. Identification...................................................................... 129
2.1.4. Sieves ................................................................................. 16 2.3.1. Identification reactions of ions and functional
2.1.5. Tubes for comparative tests ............................................ 17 groups ...................................................................................... 129
2.1.6. Gas detector tubes............................................................ 17 2.3.2. Identification of fatty oils by thin-layer
2.2. Physical and physico-chemical methods.......................... 21 chromatography...................................................................... 132
2.2.1. Clarity and degree of opalescence of liquids ................ 21 2.3.3. Identification of phenothiazines by thin-layer
2.2.10. Viscosity - Rotating viscometer method ..................... 28 chromatography...................................................................... 133
2.2.11. Distillation range ........................................................... 30 2.3.4. Odour .............................................................................. 133
2.2.12. Boiling point................................................................... 31 2.4. Limit tests........................................................................... 137
2.2.13. Determination of water by distillation ........................ 31 2.4.1. Ammonium .................................................................... 137
2.2.14. Melting point - capillary method................................. 32 2.4.10. Lead in sugars............................................................... 142
2.2.15. Melting point - open capillary method ....................... 33 2.4.11. Phosphates .................................................................... 142
2.2.16. Melting point - instantaneous method........................ 33 2.4.12. Potassium ...................................................................... 142
2.2.17. Drop point ...................................................................... 33 2.4.13. Sulfates........................................................................... 142
2.2.18. Freezing point................................................................. 35 2.4.14. Sulfated ash ................................................................... 142
2.2.19. Amperometric titration................................................. 35 2.4.15. Nickel in polyols........................................................... 143
2.2.2. Degree of coloration of liquids....................................... 22 2.4.16. Total ash ........................................................................ 143
2.2.20. Potentiometric titration ................................................ 35 2.4.17. Aluminium ................................................................... 143
2.2.21. Fluorimetry..................................................................... 36 2.4.18. Free formaldehyde ....................................................... 143
2.2.22. Atomic emission spectrometry .................................... 36 2.4.19. Alkaline impurities in fatty oils.................................. 144
2.2.23. Atomic absorption spectrometry ................................. 37 2.4.2. Arsenic............................................................................. 137
2.2.24. Absorption spectrophotometry, infrared.................... 39 2.4.20. Determination of elemental impurities..................... 144
2.2.25. Absorption spectrophotometry, ultraviolet and 2.4.21. Foreign oils in fatty oils by thin-layer
visible ......................................................................................... 42 chromatography...................................................................... 147
2.2.26. Paper chromatography .................................................. 46 2.4.22. Composition of fatty acids by gas chromatography.. 147
2.2.27. Thin-layer chromatography.......................................... 47 2.4.23. Sterols in fatty oils........................................................ 150
2.2.28. Gas chromatography...................................................... 48 2.4.24. Identification and control of residual solvents ......... 152
2.2.29. Liquid chromatography................................................. 49 2.4.25. Ethylene oxide and dioxan.......................................... 157
2.2.3. Potentiometric determination of pH ............................. 24 2.4.26. N,N-Dimethylaniline ................................................... 158
2.2.30. Size-exclusion chromatography ................................... 51 2.4.27. Heavy metals in herbal drugs and herbal drug
2.2.31. Electrophoresis ............................................................... 51 preparations ............................................................................ 158
2.2.32. Loss on drying................................................................ 57 2.4.28. 2-Ethylhexanoic acid ................................................... 160
2.2.33. Nuclear magnetic resonance spectrometry ................ 58 2.4.29. Composition of fatty acids in oils rich in omega-3
2.2.34. Thermal analysis ............................................................ 61 acids.......................................................................................... 161
2.2.35. Osmolality....................................................................... 63 2.4.3. Calcium ........................................................................... 138
2.2.36. Potentiometric determination of ionic 2.4.30. Ethylene glycol and diethylene glycol in ethoxylated
concentration using ion-selective electrodes ........................ 64 substances................................................................................ 163
2.2.37. X-ray fluorescence spectrometry ................................. 65 2.4.31. Nickel in hydrogenated vegetable oils ....................... 163
2.2.38. Conductivity ................................................................... 66 2.4.32. Total cholesterol in oils rich in omega-3 acids ......... 163
2.2.39. Molecular mass distribution in dextrans .................... 68 2.4.4. Chlorides......................................................................... 138
2.2.4. Approximate pH of solutions ......................................... 25 2.4.5. Fluorides.......................................................................... 138
2.2.40. Near-infrared spectroscopy .......................................... 70 2.4.6. Magnesium ..................................................................... 138
2.2.41. Circular dichroism......................................................... 75 2.4.7. Magnesium and alkaline-earth metals ........................ 139
2.2.42. Density of solids............................................................. 76 2.4.8. Heavy metals................................................................... 139
2.2.43. Mass spectrometry......................................................... 77 2.4.9. Iron .................................................................................. 142
2.2.44. Total organic carbon in water for pharmaceutical 2,4-Dichlorobenzyl alcohol ................................................... 2390
use............................................................................................... 79 2.5. Assays ................................................................................. 167
2.2.45. Supercritical fluid chromatography ............................. 80 2.5.1. Acid value........................................................................ 167
2.2.46. Chromatographic separation techniques .................... 80 2.5.10. Oxygen-flask method .................................................. 170
2.2.47. Capillary electrophoresis............................................... 87 2.5.11. Complexometric titrations.......................................... 170
2.2.48. Raman spectroscopy...................................................... 92 2.5.12. Water : semi-micro determination ............................. 171
2.2.49. Falling ball and automatic rolling ball viscometer 2.5.13. Aluminium in adsorbed vaccines .............................. 171
methods ..................................................................................... 94 2.5.14. Calcium in adsorbed vaccines .................................... 172
2.2.5. Relative density................................................................. 25 2.5.15. Phenol in immunosera and vaccines......................... 172
2.2.54. Isoelectric focusing ........................................................ 95 2.5.16. Protein in polysaccharide vaccines ............................ 172
2.2.55. Peptide mapping ............................................................ 97 2.5.17. Nucleic acids in polysaccharide vaccines .................. 172
2.2.56. Amino acid analysis..................................................... 100 2.5.18. Phosphorus in polysaccharide vaccines .................... 172
2.2.57. Inductively coupled plasma-atomic emission 2.5.19. O-Acetyl in polysaccharide vaccines ......................... 173
spectrometry ........................................................................... 106 2.5.2. Ester value....................................................................... 167
2.2.58. Inductively coupled plasma-mass spectrometry...... 108 2.5.20. Hexosamines in polysaccharide vaccines.................. 173
2.2.59. Glycan analysis of glycoproteins ................................ 109 2.5.21. Methylpentoses in polysaccharide vaccines.............. 173
2.2.6. Refractive index................................................................ 26 2.5.22. Uronic acids in polysaccharide vaccines ................... 174
2.2.61. Characterisation of crystalline solids by 2.5.23. Sialic acid in polysaccharide vaccines ....................... 174
microcalorimetry and solution calorimetry........................ 115 2.5.24. Carbon dioxide in gases .............................................. 174
2.2.63. Direct amperometric and pulsed electrochemical 2.5.25. Carbon monoxide in gases ......................................... 175
detection .................................................................................. 117 2.5.26. Nitrogen monoxide and nitrogen dioxide in gases.. 176
2.2.64. Peptide identification by nuclear magnetic resonance 2.5.27. Oxygen in gases............................................................ 176
spectrometry ........................................................................... 118 2.5.28. Water in gases............................................................... 176
2.2.65. Voltametric titration .................................................... 119 2.5.29. Sulfur dioxide ............................................................... 177
General Notices (1) apply to all monographs and other texts 4259
Index EUROPEAN PHARMACOPOEIA 10.0
2.5.3. Hydroxyl value ............................................................... 167 2.7.13. Assay of human anti-D immunoglobulin ................. 282
2.5.30. Oxidising substances ................................................... 177 2.7.14. Assay of hepatitis A vaccine ....................................... 284
2.5.31. Ribose in polysaccharide vaccines ............................. 177 2.7.15. Assay of hepatitis B vaccine (rDNA) ......................... 285
2.5.32. Water : micro determination....................................... 178 2.7.16. Assay of pertussis vaccine (acellular) ........................ 286
2.5.33. Total protein ................................................................. 178 2.7.17. Assay of human antithrombin III .............................. 288
2.5.34. Acetic acid in synthetic peptides................................ 181 2.7.18. Assay of human coagulation factor II ....................... 288
2.5.35. Nitrous oxide in gases ................................................. 182 2.7.19. Assay of human coagulation factor X........................ 289
2.5.36. Anisidine value............................................................. 182 2.7.2. Microbiological assay of antibiotics............................. 262
2.5.37. Methyl, ethyl and isopropyl methanesulfonate in 2.7.20. In vivo assay of poliomyelitis vaccine (inactivated).. 289
methanesulfonic acid ............................................................. 182 2.7.21. Assay of human von Willebrand factor..................... 290
2.5.38. Methyl, ethyl and isopropyl methanesulfonate in active 2.7.22. Assay of human coagulation factor XI ...................... 291
substances................................................................................ 183 2.7.23. Numeration of CD34/CD45+ cells in haematopoietic
2.5.39. Methanesulfonyl chloride in methanesulfonic products ................................................................................... 292
acid ........................................................................................... 184 2.7.24. Flow cytometry ............................................................ 293
2.5.4. Iodine value .................................................................... 167 2.7.25. Assay of human plasmin inhibitor............................. 295
2.5.40. Methyl, ethyl and isopropyl toluenesulfonate in active 2.7.27. Flocculation value (Lf) of diphtheria and tetanus toxins
substances................................................................................ 185 and toxoids (Ramon assay) ................................................... 295
2.5.41. Methyl, ethyl and isopropyl benzenesulfonate in active 2.7.28. Colony-forming cell assay for human
substances................................................................................ 186 haematopoietic progenitor cells............................................ 296
2.5.5. Peroxide value................................................................. 168 2.7.29. Nucleated cell count and viability.............................. 297
2.5.6. Saponification value....................................................... 169 2.7.30. Assay of human protein C .......................................... 299
2.5.7. Unsaponifiable matter ................................................... 169 2.7.31. Assay of human protein S ........................................... 300
2.5.8. Determination of primary aromatic amino- 2.7.32. Assay of human α-1-proteinase inhibitor ................. 300
nitrogen.................................................................................... 169 2.7.34. Assay of human C1-esterase inhibitor ...................... 301
2.5.9. Determination of nitrogen by sulfuric acid 2.7.35. Immunonephelometry for vaccine component
digestion .................................................................................. 170 assay ......................................................................................... 301
2.6. Biological tests ................................................................... 191 2.7.4. Assay of human coagulation factor VIII ..................... 268
2.6.1. Sterility ............................................................................ 191 2.7.5. Assay of heparin............................................................. 269
2.6.10. Histamine...................................................................... 200 2.7.6. Assay of diphtheria vaccine (adsorbed) ...................... 269
2.6.11. Depressor substances................................................... 200 2.7.7. Assay of pertussis vaccine (whole cell)........................ 274
2.6.12. Microbiological examination of non-sterile products : 2.7.8. Assay of tetanus vaccine (adsorbed)............................ 275
microbial enumeration tests.................................................. 201 2.7.9. Test for Fc function of immunoglobulin..................... 279
2.6.13. Microbiological examination of non-sterile products : 2.8. Methods in pharmacognosy ............................................ 305
test for specified micro-organisms ....................................... 205 2.8.1. Ash insoluble in hydrochloric acid .............................. 305
2.6.14. Bacterial endotoxins .................................................... 209 2.8.10. Solubility in alcohol of essential oils.......................... 306
2.6.15. Prekallikrein activator ................................................. 213 2.8.11. Assay of 1,8-cineole in essential oils.......................... 307
2.6.16. Tests for extraneous agents in viral vaccines for human 2.8.12. Essential oils in herbal drugs...................................... 307
use............................................................................................. 214 2.8.13. Pesticide residues ......................................................... 308
2.6.17. Test for anticomplementary activity of 2.8.14. Tannins in herbal drugs .............................................. 310
immunoglobulin..................................................................... 216 2.8.15. Bitterness value............................................................. 310
2.6.18. Test for neurovirulence of live virus vaccines .......... 218 2.8.16. Dry residue of extracts ................................................ 311
2.6.2. Mycobacteria .................................................................. 194 2.8.17. Loss on drying of extracts........................................... 311
2.6.20. Anti-A and anti-B haemagglutinins .......................... 218 2.8.18. Determination of aflatoxin B1 in herbal drugs ......... 311
2.6.21. Nucleic acid amplification techniques....................... 219 2.8.2. Foreign matter ................................................................ 305
2.6.22. Activated coagulation factors ..................................... 224 2.8.20. Herbal drugs : sampling and sample preparation .... 313
2.6.24. Avian viral vaccines : tests for extraneous agents in 2.8.21. Test for aristolochic acids in herbal drugs ................ 314
seed lots ................................................................................... 224 2.8.22. Determination of ochratoxin A in herbal drugs ...... 316
2.6.25. Avian live virus vaccines : tests for extraneous agents in 2.8.23. Microscopic examination of herbal drugs ................ 317
batches of finished product ................................................... 227 2.8.24. Foam index ................................................................... 317
2.6.26. Test for anti-D antibodies in human immunoglobu- 2.8.25. High-performance thin-layer chromatography of
lin.............................................................................................. 230 herbal drugs and herbal drug preparations ........................ 318
2.6.27. Microbiological examination of cell-based 2.8.3. Stomata and stomatal index.......................................... 305
preparations ............................................................................ 231 2.8.4. Swelling index................................................................. 306
2.6.30. Monocyte-activation test............................................. 233 2.8.5. Water in essential oils .................................................... 306
2.6.31. Microbiological examination of herbal medicinal 2.8.6. Foreign esters in essential oils ...................................... 306
products for oral use and extracts used in their 2.8.7. Fatty oils and resinified essential oils in essential
preparation .............................................................................. 239 oils ............................................................................................ 306
2.6.33. Residual pertussis toxin............................................... 241 2.8.8. Odour and taste of essential oils .................................. 306
2.6.34. Host-cell protein assays............................................... 244 2.8.9. Residue on evaporation of essential oils ..................... 306
2.6.35. Quantification and characterisation of residual 2.9. Pharmaceutical technical procedures ............................. 323
host-cell DNA ......................................................................... 248 2.9.1. Disintegration of tablets and capsules......................... 323
2.6.36. Microbiological examination of live biotherapeutic 2.9.10. Ethanol content ............................................................ 339
products : tests for enumeration of microbial 2.9.11. Test for methanol and 2-propanol ............................. 342
contaminants........................................................................... 250 2.9.12. Sieve test........................................................................ 343
2.6.38. Microbiological examination of live biotherapeutic 2.9.14. Specific surface area by air permeability................... 343
products : tests for specified micro-organisms.................... 255 2.9.16. Flowability..................................................................... 346
2.6.7. Mycoplasmas .................................................................. 194 2.9.17. Test for extractable volume of parenteral
2.6.8. Pyrogens.......................................................................... 199 preparations ............................................................................ 347
2.7. Biological assays ................................................................ 261 2.9.18. Preparations for inhalation : aerodynamic assessment
2.7.1. Immunochemical methods........................................... 261 of fine particles........................................................................ 347
2.7.10. Assay of human coagulation factor VII .................... 280 2.9.19. Particulate contamination : sub-visible particles...... 360
2.7.11. Assay of human coagulation factor IX ...................... 281 2.9.2. Disintegration of suppositories and pessaries ............ 325
2.7.12. Assay of heparin in coagulation factors .................... 281 2.9.20. Particulate contamination : visible particles ............. 362
4260 See the information section on general monographs (cover pages)

EUROPEAN PHARMACOPOEIA 10.0 Index
2.9.22. Softening time determination of lipophilic 3.2.2.1. Plastic containers for aqueous solutions for
suppositories ........................................................................... 363 infusion .................................................................................... 460
2.9.23. Gas pycnometric density of solids ............................. 364 3.2.3. Sterile plastic containers for human blood and
2.9.25. Dissolution test for medicated chewing gums ......... 365 blood components (see 3.3.4.) .............................................. 471
2.9.26. Specific surface area by gas adsorption ..................... 369 3.2.4. Empty sterile containers of plasticised poly(vinyl
2.9.27. Uniformity of mass of delivered doses from multidose chloride) for human blood and blood components (see
containers ................................................................................ 372 3.3.5.)........................................................................................ 473
2.9.29. Intrinsic dissolution..................................................... 372 3.2.5. Sterile containers of plasticised poly(vinyl chloride)
2.9.3. Dissolution test for solid dosage forms ....................... 326 for human blood containing anticoagulant solution (see
2.9.31. Particle size analysis by laser light diffraction.......... 373 3.3.6.)........................................................................................ 474
2.9.32. Porosity and pore-size distribution of solids by 3.2.6. Sets for the transfusion of blood and blood components
mercury porosimetry ............................................................. 377 (see 3.3.7.)................................................................................ 475
2.9.33. Characterisation of crystalline and partially crystalline 3.2.8. Sterile single-use plastic syringes (see 3.3.8.) ............. 477
solids by X-ray powder diffraction (XRPD) ....................... 379 3.2.9. Rubber closures for containers for aqueous
2.9.34. Bulk density and tapped density of powders............ 384 parenteral preparations, for powders and for
2.9.35. Powder fineness............................................................ 387 freeze-dried powders.............................................................. 460
2.9.36. Powder flow .................................................................. 387 3.3. Containers for human blood and blood components, and
2.9.37. Optical microscopy...................................................... 390 materials used in their manufacture; transfusion sets and
2.9.38. Particle-size distribution estimation by analytical materials used in their manufacture; syringes .................... 463
sieving ...................................................................................... 392 3.3.1. Materials for containers for human blood and blood
2.9.39. Water-solid interactions : determination of components ............................................................................. 465
sorption-desorption isotherms and of water activity......... 394 3.3.2. Materials based on plasticised poly(vinyl chloride) for
2.9.4. Dissolution test for transdermal patches .................... 333 containers for human blood and blood components......... 465
2.9.40. Uniformity of dosage units ......................................... 398 3.3.3. Materials based on plasticised poly(vinyl chloride) for
2.9.41. Friability of granules and spheroids .......................... 400 tubing used in sets for the transfusion of blood and blood
2.9.42. Dissolution test for lipophilic solid dosage forms ... 401 components ............................................................................. 468
2.9.43. Apparent dissolution ................................................... 403 3.3.4. Sterile plastic containers for human blood and
2.9.44. Preparations for nebulisation : characterisation....... 404 blood components .................................................................. 471
2.9.45. Wettability of porous solids including powders....... 406 3.3.5. Empty sterile containers of plasticised poly(vinyl
2.9.47. Demonstration of uniformity of dosage units using chloride) for human blood and blood components........... 473
large sample sizes.................................................................... 409 3.3.6. Sterile containers of plasticised poly(vinyl chloride) for
2.9.49. Powder flow properties by shear cell methods......... 411 human blood containing anticoagulant solution ............... 474
2.9.5. Uniformity of mass of single-dose preparations ........ 335 3.3.7. Sets for the transfusion of blood and blood
2.9.52. Scanning electron microscopy ................................... 414 components ............................................................................. 475
2.9.6. Uniformity of content of single-dose preparations.... 336 3.3.8. Sterile single-use plastic syringes ................................. 477
2.9.7. Friability of uncoated tablets ........................................ 336 3-O-Desacyl-4′-monophosphoryl lipid A............................ 2355
2.9.8. Resistance to crushing of tablets .................................. 337 4. Reagents................................................................................. 481
2.9.9. Measurement of consistency by penetrometry .......... 337 4.1. Reagents, standard solutions, buffer solutions .............. 481
3.1. Materials used for the manufacture of containers ........ 423 4.1.1. Reagents .......................................................................... 481
3.1.1. Materials for containers for human blood and blood 4.1.2. Standard solutions for limit tests ................................. 598
components (see 3.3.1.) ......................................................... 465 4.1.3. Buffer solutions .............................................................. 602
3.1.10. Materials based on non-plasticised poly(vinyl chloride) 4.2. Volumetric analysis........................................................... 609
for containers for non-injectable, aqueous solutions......... 437 4.2.1. Primary standards for volumetric solutions............... 609
3.1.11. Materials based on non-plasticised poly(vinyl 4.2.2. Volumetric solutions...................................................... 609
chloride) for containers for solid dosage forms for oral 4-Aminobenzoic acid ............................................................. 1819
administration......................................................................... 439 5.1. General texts on microbiology ........................................ 619
3.1.1.1. Materials based on plasticised poly(vinyl chloride) 5.10. Control of impurities in substances for pharmaceutical
for containers for human blood and blood components (see use............................................................................................. 763
3.3.2.)........................................................................................ 465 5.11. Characters section in monographs ............................... 769
3.1.1.2. Materials based on plasticised poly(vinyl chloride) for 5.1.1. Methods of preparation of sterile products ................ 619
tubing used in sets for the transfusion of blood and blood 5.1.10. Guidelines for using the test for bacterial
components (see 3.3.3.) ......................................................... 468 endotoxins ............................................................................... 639
3.1.13. Plastic additives ............................................................ 441 5.1.11. Determination of bactericidal, fungicidal or yeasticidal
3.1.14. Materials based on plasticised poly(vinyl chloride) activity of antiseptic medicinal products............................. 643
for containers for aqueous solutions for intravenous 5.1.2. Biological indicators and related microbial preparations
infusion .................................................................................... 445 used in the manufacture of sterile products........................ 622
3.1.15. Polyethylene terephthalate for containers for 5.12. Reference standards ........................................................ 773
preparations not for parenteral use ...................................... 448 5.1.3. Efficacy of antimicrobial preservation ........................ 625
3.1.3. Polyolefins ....................................................................... 423 5.14. Gene transfer medicinal products for human use ...... 779
3.1.4. Polyethylene without additives for containers for 5.1.4. Microbiological quality of non-sterile pharmaceutical
parenteral preparations and for ophthalmic preparations.. 426 preparations and substances for pharmaceutical use......... 627
3.1.5. Polyethylene with additives for containers for parenteral 5.1.5. Application of the F0 concept to steam sterilisation of
preparations and for ophthalmic preparations ................... 427 aqueous preparations ............................................................. 628
3.1.6. Polypropylene for containers and closures for parenteral 5.15. Functionality-related characteristics of excipients...... 793
preparations and ophthalmic preparations ......................... 431 5.1.6. Alternative methods for control of microbiological
3.1.7. Poly(ethylene - vinyl acetate) for containers and tubing quality ...................................................................................... 628
for total parenteral nutrition preparations .......................... 434 5.16. Crystallinity ..................................................................... 797
3.1.8. Silicone oil used as a lubricant ..................................... 436 5.17. Recommendations on methods for dosage forms
3.1.9. Silicone elastomer for closures and tubing ................. 436 testing....................................................................................... 801
3.2. Containers.......................................................................... 453 5.1.7. Viral safety ...................................................................... 637
3.2.1. Glass containers for pharmaceutical use..................... 453 5.17.1. Recommendations on dissolution testing................. 801
3.2.2. Plastic containers and closures for pharmaceutical 5.1.8. Microbiological quality of herbal medicinal products for
use............................................................................................. 459 oral use and extracts used in their preparation .................. 638
5.19. Extemporaneous preparation of radiopharmaceuti- β-Acetyldigoxin....................................................................... 1750

cals ............................................................................................ 807 Acetylene intermix (1 per cent) in nitrogen........................ 1752
5.1.9. Guidelines for using the test for sterility..................... 639 Acetylsalicylic acid ................................................................. 1753
5.2. General texts on biological products .............................. 647 Acetyltryptophan, N- ............................................................. 1755
5.20. Elemental impurities ...................................................... 815 Acetyltyrosine, N-................................................................... 1757
5.21. Chemometric methods applied to analytical data ...... 819 Achyranthes bidentata root ................................................... 1293
5.2.1. Terminology used in monographs on biological Aciclovir................................................................................... 1758
products ................................................................................... 647 Acid value (2.5.1.)..................................................................... 167
5.2.11. Carrier proteins for the production of conjugated Acidum picrinicum for homoeopathic preparations ......... 1698
polysaccharide vaccines for human use............................... 674 Acidum succinicum for homoeopathic preparations ........ 1698
5.2.12. Raw materials of biological origin for the production Acitretin ................................................................................... 1760
of cell-based and gene therapy medicinal products ........... 675 Actinobacillosis vaccine (inactivated), porcine .................. 1139
5.2.13. Healthy chicken flocks for the production of inactivated Activated charcoal .................................................................. 2162
vaccines for veterinary use .................................................... 679 Activated coagulation factors (2.6.22.)................................... 224
5.2.14. Substitution of in vivo method(s) by in vitro method(s) Adapalene ................................................................................ 1761
for the quality control of vaccines ........................................ 679 Additives, plastic (3.1.13.) ....................................................... 441
5.2.2. Chicken flocks free from specified pathogens for the Adenine.................................................................................... 1762
production and quality control of vaccines......................... 647 Adenosine ................................................................................ 1763
5.22. Names of herbal drugs used in traditional Chinese Adenovirus vaccine (inactivated), canine............................ 1079
medicine .................................................................................. 839 Adenovirus vaccine (live), canine......................................... 1080
5.2.3. Cell substrates for the production of vaccines for human Adipic acid............................................................................... 1765
use............................................................................................. 650 Adrenaline ............................................................................... 1766
5.23. Monographs on herbal drug extracts (information Adrenaline tartrate ................................................................. 1767
chapter) .................................................................................... 843 Adsorption, gas, specific surface area by (2.9.26.)................ 369
5.2.4. Cell cultures for the production of veterinary Aerodynamic assessment of fine particles in preparations for
vaccines.................................................................................... 654 inhalation (2.9.18.) ................................................................. 347
5.24. Chemical imaging ........................................................... 847 Aflatoxin B1 in herbal drugs, determination of (2.8.18.) ..... 311
5.25. Process analytical technology........................................ 855 Agar .......................................................................................... 1295
5.2.5. Substances of animal origin for the production of Agaricus phalloides for homoeopathic preparations ......... 1699
immunological veterinary medicinal products .................. 656 Agnus castus fruit ................................................................... 1295
5.2.6. Evaluation of safety of veterinary vaccines and Agnus castus fruit dry extract ............................................... 1296
immunosera ........................................................................... 658 Agrimony................................................................................. 1297
5.2.7. Evaluation of efficacy of veterinary vaccines and Air, medicinal ......................................................................... 1768
immunosera ............................................................................ 661 Air, synthetic medicinal......................................................... 1770
5.2.8. Minimising the risk of transmitting animal spongiform Akebia stem ............................................................................. 1298
encephalopathy agents via human and veterinary medicinal Alanine..................................................................................... 1771
products ................................................................................... 661 Albendazole............................................................................. 1773
5.2.9. Evaluation of safety of each batch of immunosera for Albumin solution, human ..................................................... 2832
veterinary use.......................................................................... 673 Alchemilla................................................................................ 1300
5.3. Statistical analysis of results of biological assays and Alcoholimetric tables (5.5.) ..................................................... 727
tests........................................................................................... 685 Alcuronium chloride.............................................................. 1774
5.4. Residual solvents ............................................................... 717 Alendronate trihydrate, sodium ........................................... 3798
5.5. Alcoholimetric tables........................................................ 727 Alexandrian senna pods ........................................................ 1622
5.6. Assay of interferons .......................................................... 741 Alfacalcidol.............................................................................. 1776
5.7. Table of physical characteristics of radionuclides Alfadex ..................................................................................... 1777
mentioned in the European Pharmacopoeia ...................... 745 Alfentanil hydrochloride hydrate ......................................... 1778
5.8. Pharmacopoeial harmonisation ...................................... 755 Alfuzosin hydrochloride ........................................................ 1780
5.9. Polymorphism ................................................................... 759 Alginate, sodium..................................................................... 3799
Alginic acid.............................................................................. 1781
A Alimemazine hemitartrate..................................................... 1782
Abacavir sulfate....................................................................... 1733 Alkaline impurities in fatty oils (2.4.19.) ............................... 144
Abbreviations and symbols (1.) .................................................. 3 Alkaline-earth metals and magnesium (2.4.7.)..................... 139
Abelmoschi corolla ................................................................. 1289 Allantoin .................................................................................. 1783
Absorption spectrophotometry, infrared (2.2.24.)................. 39 Allergen products ..................................................................... 861
Absorption spectrophotometry, ultraviolet and visible Allergen products, animal epithelia and outgrowths for... 1854
(2.2.25.) ...................................................................................... 42 Allergen products, Hymenoptera venoms for..................... 2908
Acacia ....................................................................................... 1290 Allergen products, mites for.................................................. 3281
Acacia, dried dispersion......................................................... 1734 Allergen products, moulds for .............................................. 3302
Acamprosate calcium ............................................................. 1736 Allergen products, pollens for............................................... 3583
Acanthopanax bark ................................................................ 1292 Allium sativum for homoeopathic preparations ................ 1701
Acarbose .................................................................................. 1736 Allopurinol .............................................................................. 1784
Acebutolol hydrochloride ...................................................... 1738 all-rac-α-Tocopherol............................................................... 4057
Aceclofenac.............................................................................. 1740 all-rac-α-Tocopheryl acetate.................................................. 4059
Acemetacin .............................................................................. 1742 Almagate .................................................................................. 1786
Acesulfame potassium............................................................ 1744 Almond oil, refined ................................................................ 1787
Acetate trihydrate, sodium .................................................... 3797 Almond oil, virgin .................................................................. 1787
Acetazolamide......................................................................... 1745 Aloes, Barbados ...................................................................... 1301
Acetic acid, glacial .................................................................. 1746 Aloes, Cape.............................................................................. 1302
Acetic acid in synthetic peptides (2.5.34.) ............................. 181 Aloes dry extract, standardised............................................. 1303
Acetone .................................................................................... 1747 Alovudine (18F) injection ....................................................... 1181
Acetylcholine chloride ........................................................... 1748 Alphacyclodextrin .................................................................. 1777
Acetylcysteine.......................................................................... 1749 Alprazolam .............................................................................. 1788
Alprenolol hydrochloride ...................................................... 1790

Alprostadil ............................................................................... 1791 Angelica archangelica root .................................................... 1309

Alteplase for injection ............................................................ 1793 Angelica dahurica root........................................................... 1310
Alternative methods for control of microbiological quality Angelica pubescens root ........................................................ 1312
(5.1.6.) ...................................................................................... 628 Angelica sinensis root ............................................................ 1314
Altizide..................................................................................... 1797 Animal anti-T lymphocyte immunoglobulin for human
Alum......................................................................................... 1798 use........................................................................................... 1858
Aluminium (2.4.17.)................................................................. 143 Animal epithelia and outgrowths for allergen products.... 1854
Aluminium chloride hexahydrate......................................... 1798 Animal immunosera for human use ...................................... 871
Aluminium hydroxide, hydrated, for adsorption ............... 1798 Animal spongiform encephalopathies, products with risk of
Aluminium in adsorbed vaccines (2.5.13.)............................ 171 transmitting agents of ............................................................ 884
Aluminium magnesium silicate ............................................ 1799 Animal spongiform encephalopathy agents, minimising the
Aluminium oxide, hydrated .................................................. 1801 risk of transmitting via human and veterinary medicinal
Aluminium phosphate gel ..................................................... 1802 products (5.2.8.)...................................................................... 661
Aluminium phosphate, hydrated.......................................... 1803 Anise oil ................................................................................... 1315
Aluminium sodium silicate ................................................... 1803 Aniseed .................................................................................... 1317
Aluminium stearate................................................................ 1804 Anisidine value (2.5.36.) .......................................................... 182
Aluminium sulfate.................................................................. 1806 Antazoline hydrochloride...................................................... 1855
Alverine citrate........................................................................ 1807 Anthrax spore vaccine (live) for veterinary use.................. 1055
Amantadine hydrochloride ................................................... 1808 Anthrax vaccine for human use (adsorbed, prepared from
Ambroxol hydrochloride ....................................................... 1809 culture filtrates)....................................................................... 947
Amfetamine sulfate ................................................................ 1810 Anti-A and anti-B haemagglutinins (2.6.20.)........................ 218
Amidotrizoate, sodium .......................................................... 3800 Antibiotics, microbiological assay of (2.7.2.) ........................ 262
Amidotrizoic acid dihydrate ................................................. 1812 Antibodies (anti-D) in human immunoglobulin, test for
Amikacin ................................................................................. 1813 (2.6.26.) .................................................................................... 230
Amikacin sulfate ..................................................................... 1815 Antibodies for human use, monoclonal ................................ 878
Amiloride hydrochloride dihydrate ..................................... 1818 Anticoagulant and preservative solutions for human blood
Amino acid analysis (2.2.56.) .................................................. 100 ................................................................................................ 1856
Aminobenzoic acid, 4- ........................................................... 1819 Anticomplementary activity of immunoglobulin (2.6.17.).. 216
Aminocaproic acid ................................................................. 1821 Anti-D antibodies in human immunoglobulin, test for
Aminoglutethimide ................................................................ 1821 (2.6.26.) .................................................................................... 230
Aminophylline ........................................................................ 4008 Anti-D immunoglobulin for intravenous administration,
Aminophylline hydrate .......................................................... 4009 human .................................................................................... 2835
Aminosalicylate dihydrate, sodium...................................... 3801 Anti-D immunoglobulin, human ......................................... 2834
Amiodarone hydrochloride................................................... 1823 Anti-D immunoglobulin, human, assay of (2.7.13.) ............ 282
Amisulpride............................................................................. 1825 Antimicrobial preservation, efficacy of (5.1.3.) .................... 625
Amitriptyline hydrochloride ................................................. 1826 Antiseptic medicinal products, determination of bactericidal,
Amlodipine besilate................................................................ 1827 fungicidal or yeasticidal activity of (5.1.11.) ....................... 643
Ammonia (13N) injection....................................................... 1183 Antiserum, European viper venom ...................................... 1174
Ammonia solution, concentrated ......................................... 1829 Anti-T lymphocyte immunoglobulin for human use,
Ammonio methacrylate copolymer (type A)...................... 1830 animal .................................................................................... 1858
Ammonio methacrylate copolymer (type B) ...................... 1831 Antithrombin III concentrate, human ................................. 2835
Ammonium (2.4.1.).................................................................. 137 Antithrombin III, human, assay of (2.7.17.) ......................... 288
Ammonium bromide ............................................................. 1832 Apis for homoeopathic preparations.................................... 1703
Ammonium carbonicum for homoeopathic prepara- Apomorphine hydrochloride hemihydrate ......................... 1862
tions........................................................................................ 1701 Apparatus (2.1.) .......................................................................... 15
Ammonium chloride.............................................................. 1832 Apparent dissolution (2.9.43.)................................................. 403
Ammonium glycyrrhizate ..................................................... 1833 Application of the F0 concept to steam sterilisation of aqueous
Ammonium hydrogen carbonate ......................................... 1834 preparations (5.1.5.) ............................................................... 628
Amobarbital ............................................................................ 1834 Approximate pH of solutions (2.2.4.)....................................... 25
Amobarbital sodium .............................................................. 1835 Aprepitant................................................................................ 1863
Amomum fruit........................................................................ 1304 Aprotinin ................................................................................. 1864
Amomum fruit, round ........................................................... 1604 Aprotinin concentrated solution .......................................... 1867
Amorolfine hydrochloride..................................................... 1836 Arachis oil, hydrogenated...................................................... 1869
Amoxicillin sodium................................................................ 1838 Arachis oil, refined ................................................................. 1870
Amoxicillin trihydrate............................................................ 1840 Arginine ................................................................................... 1870
Amperometric detection, direct, and pulsed electrochemical Arginine aspartate .................................................................. 1871
detection (2.2.63.)................................................................... 117 Arginine hydrochloride ......................................................... 1872
Amperometric titration (2.2.19.) .............................................. 35 Argon ....................................................................................... 1873
Amphotericin B ...................................................................... 1842 Aripiprazole............................................................................. 1874
Ampicillin................................................................................ 1844 Aristolochic acids in herbal drugs, test for (2.8.21) ............. 314
Ampicillin sodium.................................................................. 1846 Arnica flower........................................................................... 1318
Ampicillin trihydrate.............................................................. 1849 Arnica tincture........................................................................ 1320
Amylmetacresol ...................................................................... 1851 Arsenic (2.4.2.).......................................................................... 137
Anacardium for homoeopathic preparations...................... 1702 Arsenicum album for homoeopathic preparations ............ 1704
Anaemia vaccine (live), chicken, infectious ........................ 1122 Arsenious trioxide for homoeopathic preparations ........... 1704
Anaesthetic ether .................................................................... 2577 Articaine hydrochloride......................................................... 1876
Analysis, thermal (2.2.34.)......................................................... 61 Artichoke leaf .......................................................................... 1321
Analytical sieving, particle-size distribution estimation by Artichoke leaf dry extract...................................................... 1323
(2.9.38.) .................................................................................... 392 Ascorbate, calcium ................................................................. 2045
Anamirta cocculus for homoeopathic preparations .......... 1708 Ascorbate, sodium .................................................................. 3802
Anastrozole.............................................................................. 1852 Ascorbic acid ........................................................................... 1877
Andrographis herb ................................................................. 1305 Ascorbyl palmitate.................................................................. 1879
Anemarrhena asphodeloides rhizome ................................. 1307 Ash insoluble in hydrochloric acid (2.8.1.) ........................... 305
Ash leaf .................................................................................... 1324 Avian viral vaccines : tests for extraneous agents in seed lots
Ash, sulfated (2.4.14.)............................................................... 142 (2.6.24.) .................................................................................... 224
Ash, total (2.4.16.) .................................................................... 143 Azaperone for veterinary use ................................................ 1900
Asparagine monohydrate....................................................... 1880 Azathioprine............................................................................ 1901
Aspartame................................................................................ 1881 Azelastine hydrochloride ....................................................... 1902
Aspartic acid............................................................................ 1883 Azithromycin .......................................................................... 1904
Assay of 1,8-cineole in essential oils (2.8.11.) ....................... 307
Assay of diphtheria vaccine (adsorbed) (2.7.6.).................... 269 B
Assay of heparin (2.7.5.) .......................................................... 269 B19 virus (B19V), validation of nucleic acid amplification
Assay of heparin in coagulation factors (2.7.12.) ................. 281 techniques for the quantification of B19V DNA in plasma
Assay of hepatitis A vaccine (2.7.14.)..................................... 284 pools : guidelines..................................................................... 219
Assay of hepatitis B vaccine (rDNA) (2.7.15.) ...................... 285 Bacampicillin hydrochloride ................................................. 1911
Assay of human α-1-proteinase inhibitor (2.7.32.) .............. 300 Bacitracin................................................................................. 1913
Assay of human anti-D immunoglobulin (2.7.13.) .............. 282 Bacitracin zinc......................................................................... 1917
Assay of human antithrombin III (2.7.17.)............................ 288 Baclofen ................................................................................... 1921
Assay of human C1-esterase inhibitor (2.7.34.).................... 301 Bacterial endotoxins (2.6.14.).................................................. 209
Assay of human coagulation factor II (2.7.18.)..................... 288 Bacterial endotoxins, guidelines for using the test for
Assay of human coagulation factor IX (2.7.11.) ................... 281 (5.1.10.) .................................................................................... 639
Assay of human coagulation factor VII (2.7.10.).................. 280 Bactericidal, fungicidal or yeasticidal activity of antiseptic
Assay of human coagulation factor VIII (2.7.4.) .................. 268 medicinal products, determination of (5.1.11.) .................. 643
Assay of human coagulation factor X (2.7.19.)..................... 289 Baical skullcap root ................................................................ 1331
Assay of human coagulation factor XI (2.7.22.) ................... 291 Bambuterol hydrochloride .................................................... 1922
Assay of human plasmin inhibitor (2.7.25.).......................... 295 Barbados aloes ........................................................................ 1301
Assay of human protein C (2.7.30.)........................................ 299 Barbary wolfberry fruit.......................................................... 1332
Assay of human protein S (2.7.31.) ........................................ 300 Barbital..................................................................................... 1923
Assay of human von Willebrand factor (2.7.21.).................. 290 Barium chloratum for homoeopathic preparations ........... 1705
Assay of interferons (5.6.)........................................................ 741 Barium chloride dihydrate for homoeopathic
Assay of pertussis vaccine (acellular) (2.7.16.)...................... 286 preparations .......................................................................... 1705
Assay of pertussis vaccine (whole cell) (2.7.7.) ..................... 274 Barium sulfate ......................................................................... 1924
Assay of poliomyelitis vaccine (inactivated), in vivo Basic butylated methacrylate copolymer ............................. 1925
(2.7.20.) .................................................................................... 289 BCG for immunotherapy......................................................... 948
Assay of tetanus vaccine (adsorbed) (2.7.8.) ......................... 275 BCG vaccine, freeze-dried....................................................... 949
Assays (2.5.)............................................................................... 167 Bearberry leaf.......................................................................... 1333
Astragalus mongholicus root ................................................ 1325 Beclometasone dipropionate ................................................. 1926
Atazanavir sulfate ................................................................... 1885 Beclometasone dipropionate monohydrate......................... 1929
Atenolol.................................................................................... 1887 Beeswax, white ........................................................................ 1931
Atomic absorption spectrometry (2.2.23.) .............................. 37 Beeswax, yellow....................................................................... 1932
Atomic emission spectrometry (2.2.22.).................................. 36 Belamcanda chinensis rhizome............................................. 1334
Atomic emission spectrometry, inductively coupled plasma- Belladonna for homoeopathic preparations........................ 1705
(2.2.57.) .................................................................................... 106 Belladonna leaf........................................................................ 1336
Atomoxetine hydrochloride .................................................. 1889 Belladonna leaf dry extract, standardised ........................... 1337
Atorvastatin calcium trihydrate............................................ 1890 Belladonna leaf tincture, standardised................................. 1338
Atovaquone.............................................................................. 1892 Belladonna, prepared ............................................................. 1339
Atractylodes lancea rhizome ................................................. 1327 Benazepril hydrochloride ...................................................... 1932
Atractylodes rhizome, largehead .......................................... 1328 Bendroflumethiazide.............................................................. 1934
Atracurium besilate ................................................................ 1894 Benperidol ............................................................................... 1935
Atropine ................................................................................... 1897 Benserazide hydrochloride .................................................... 1936
Atropine sulfate....................................................................... 1898 Bentonite.................................................................................. 1938
Aucklandia root ...................................................................... 1329 Benzalkonium chloride.......................................................... 1938
Aujeszky’s disease vaccine (inactivated) for pigs ................ 1055 Benzalkonium chloride solution........................................... 1940
Aujeszky’s disease vaccine (live) for pigs for parenteral Benzathine benzylpenicillin tetrahydrate ............................ 1951
administration....................................................................... 1057 Benzathine penicillin G tetrahydrate ................................... 1951
Aurothiomalate, sodium ........................................................ 3804 Benzathine penicillin V tetrahydrate ................................... 3531
Aurum chloratum natronatum for homoeopathic Benzathine phenoxymethylpenicillin tetrahydrate ............ 3531
preparations .......................................................................... 1704 Benzbromarone....................................................................... 1942
Automatic rolling ball and falling ball viscometer methods Benzenesulfonate (methyl, ethyl and isopropyl) in active
(2.2.49.) ...................................................................................... 94 substances (2.5.41.)................................................................. 186
Avian infectious bronchitis vaccine (inactivated)............... 1059 Benzethonium chloride ......................................................... 1943
Avian infectious bronchitis vaccine (live)............................ 1060 Benzocaine............................................................................... 1944
Avian infectious bursal disease vaccine (inactivated) ........ 1062 Benzoic acid ............................................................................ 1945
Avian infectious bursal disease vaccine (live) ..................... 1063 Benzoin, Siam ......................................................................... 1341
Avian infectious encephalomyelitis vaccine (live) .............. 1065 Benzoin, Sumatra.................................................................... 1341
Avian infectious laryngotracheitis vaccine (live)................ 1066 Benzoin tincture, Siam........................................................... 1342
Avian live virus vaccines : tests for extraneous agents in batches Benzoin tincture, Sumatra..................................................... 1343
of finished product (2.6.25.).................................................. 227 Benzoyl peroxide, hydrous .................................................... 1946
Avian paramyxovirus 1 (Newcastle disease) vaccine Benzydamine hydrochloride ................................................. 1947
(inactivated) .......................................................................... 1134 Benzyl alcohol ......................................................................... 1949
Avian paramyxovirus 1 (Newcastle disease) vaccine Benzyl benzoate ...................................................................... 1950
(live) ....................................................................................... 1136 Benzylpenicillin (benzathine) tetrahydrate ......................... 1951
Avian paramyxovirus 3 vaccine (inactivated) for turkeys.. 1068 Benzylpenicillin potassium ................................................... 1953
Avian tuberculin purified protein derivative....................... 4119 Benzylpenicillin (procaine) monohydrate........................... 1955
Avian viral tenosynovitis vaccine (live) ............................... 1069 Benzylpenicillin sodium ........................................................ 1957

Betacarotene ............................................................................ 1959 Blood containing anticoagulant solution, human, sterile

Betacyclodextrin ..................................................................... 1960 containers of plasticised poly(vinyl chloride) for (3.3.6.).. 474
Betacyclodextrin, poly(hydroxypropyl) ether ..................... 2901 Blood, human anticoagulant and preservative solutions
Betacyclodextrin, sodium 4-sulfonatobutyl ether .............. 3935 for ........................................................................................... 1856
Betadex..................................................................................... 1960 Bogbean leaf ............................................................................ 1360
Betahistine dihydrochloride.................................................. 1962 Boiling point (2.2.12.) ................................................................ 31
Betahistine mesilate................................................................ 1963 Boldine ..................................................................................... 1990
Betamethasone ........................................................................ 1964 Boldo leaf................................................................................. 1361
Betamethasone acetate ........................................................... 1966 Boldo leaf dry extract............................................................. 1363
Betamethasone dipropionate................................................. 1968 Borage (starflower) oil, refined ............................................. 1992
Betamethasone sodium phosphate....................................... 1970 Borax ........................................................................................ 1992
Betamethasone valerate ......................................................... 1971 Bordetella bronchiseptica vaccine (live) for dogs............... 1070
Betaxolol hydrochloride......................................................... 1973 Boric acid................................................................................. 1993
Bezafibrate ............................................................................... 1975 Botulinum antitoxin ............................................................... 1169
Bicalutamide............................................................................ 1976 Botulinum toxin type A for injection .................................. 1993
Bifonazole ................................................................................ 1977 Botulinum toxin type B for injection ................................... 1995
Bilberry fruit, dried ................................................................ 1343 Bovine insulin ......................................................................... 2946
Bilberry fruit dry extract, fresh, refined and standardised.. 1442 Bovine leptospirosis vaccine (inactivated) .......................... 1071
Bilberry fruit, fresh................................................................. 1344 Bovine parainfluenza virus vaccine (live)............................ 1073
Biological assays (2.7.) ............................................................. 261 Bovine respiratory syncytial virus vaccine (live) ................ 1074
Biological assays and tests, statistical analysis of results of Bovine rhinotracheitis vaccine (inactivated), infectious ... 1120
(5.3.) ......................................................................................... 685 Bovine rhinotracheitis vaccine (live), infectious ................ 1121
Biological indicators and related microbial preparations used Bovine serum .......................................................................... 1996
in the manufacture of sterile products (5.1.2.) ................... 622 Bovine tuberculin purified protein derivative..................... 4120
Biological products, general texts on (5.2.) ........................... 647 Bovine viral diarrhoea vaccine (inactivated) ...................... 1075
Biological products, terminology used in monographs on Brimonidine tartrate .............................................................. 1998
(5.2.1.) ...................................................................................... 647 Bromazepam ........................................................................... 1999
Biological tests (2.6.) ................................................................ 191 Bromhexine hydrochloride.................................................... 2000
Biotherapeutic products for human use, live ........................ 876 Bromocriptine mesilate.......................................................... 2001
Biotherapeutic products (live), microbiological examination of Bromperidol ............................................................................ 2003
(tests for enumeration of microbial contaminants) (2.6.36.) Bromperidol decanoate.......................................................... 2005
.................................................................................................. 250 Brompheniramine maleate .................................................... 2007
Biotherapeutic products (live), microbiological examination Bronchitis vaccine (inactivated), infectious, avian ............. 1059
of (tests for specified micro-organisms) (2.6.38.)............... 255 Bronchitis vaccine (live), infectious, avian .......................... 1060
Biotin........................................................................................ 1979 Brotizolam ............................................................................... 2008
Biperiden hydrochloride........................................................ 1980 Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain) for
Biphasic insulin injection ...................................................... 2953 veterinary use........................................................................ 1076
Biphasic isophane insulin injection...................................... 2953 Buccal tablets and sublingual tablets...................................... 922
Birch leaf .................................................................................. 1345 Buckwheat herb ...................................................................... 1364
Bisacodyl.................................................................................. 1982 Budesonide .............................................................................. 2009
Bismuth subcarbonate............................................................ 1983 Bufexamac ............................................................................... 2011
Bismuth subgallate.................................................................. 1984 Buffer solutions (4.1.3.)............................................................ 602
Bismuth subnitrate, heavy ..................................................... 1985 Buflomedil hydrochloride...................................................... 2012
Bismuth subsalicylate............................................................. 1986 Bulk density and tapped density of powders (2.9.34.) ......... 384
Bisoprolol fumarate ................................................................ 1986 Bumetanide ............................................................................. 2014
Bistort rhizome ....................................................................... 1347 Bupivacaine hydrochloride.................................................... 2015
Bitter fennel ............................................................................. 1433 Bupleurum root ...................................................................... 1365
Bitter-fennel fruit oil .............................................................. 1348 Buprenorphine ........................................................................ 2017
Bitter-fennel herb oil .............................................................. 1350 Buprenorphine hydrochloride .............................................. 2019
Bitterness value (2.8.15.) .......................................................... 310 Bursal disease vaccine (inactivated), infectious, avian....... 1062
Bitter-orange epicarp and mesocarp .................................... 1352 Bursal disease vaccine (live), infectious, avian.................... 1063
Bitter-orange flower................................................................ 1353 Buserelin .................................................................................. 2020
Bitter-orange-epicarp and mesocarp tincture..................... 1353 Buspirone hydrochloride ....................................................... 2022
Bitter-orange-flower oil.......................................................... 1550 Busulfan ................................................................................... 2024
Black cohosh............................................................................ 1355 Butcher’s broom ...................................................................... 1367
Black horehound..................................................................... 1358 Butyl parahydroxybenzoate................................................... 2025
Blackcurrant leaf ..................................................................... 1359 Butylated methacrylate copolymer, basic ............................ 1925
Bleomycin sulfate.................................................................... 1989 Butylhydroxyanisole ............................................................... 2026
Blood and blood components, human, empty sterile containers Butylhydroxytoluene .............................................................. 2027
of plasticised poly(vinyl chloride) for (3.3.5.)..................... 473
Blood and blood components, human, materials based C
on plasticised poly(vinyl chloride) for containers for Cabergoline ............................................................................. 2031
(3.3.2.) ...................................................................................... 465 Cachets....................................................................................... 907
Blood and blood components, human, materials for containers Cadmium sulfate hydrate for homoeopathic prepara-
for (3.3.1.) ................................................................................ 465 tions........................................................................................ 1707
Blood and blood components, human, sterile plastic Cadmium sulfuricum for homoeopathic preparations...... 1707
containers for (3.3.4.)............................................................. 471 Caffeine .................................................................................... 2032
Blood and blood components, materials based on plasticised Caffeine monohydrate............................................................ 2033
poly(vinyl chloride) for tubing used in sets for the transfusion Calcifediol monohydrate ....................................................... 2035
of (3.3.3.).................................................................................. 468 Calcipotriol.............................................................................. 2036
Blood and blood components, sets for the transfusion of Calcipotriol monohydrate ..................................................... 2038
(3.3.7.) ...................................................................................... 475 Calcitonin (salmon)................................................................ 2040
Calcitriol .................................................................................. 2043 Captopril .................................................................................. 2075

Calcium (2.4.3.)......................................................................... 138 Caraway fruit........................................................................... 1376
Calcium acetate....................................................................... 2044 Caraway oil .............................................................................. 1377
Calcium ascorbate .................................................................. 2045 Carbachol................................................................................. 2078
Calcium carbonate.................................................................. 2046 Carbamazepine ....................................................................... 2078
Calcium carboxymethylcellulose .......................................... 2093 Carbasalate calcium................................................................ 2080
Calcium chloride dihydrate................................................... 2047 Carbidopa ................................................................................ 2081
Calcium chloride hexahydrate .............................................. 2047 Carbimazole ............................................................................ 2083
Calcium dobesilate monohydrate ......................................... 2048 Carbocisteine........................................................................... 2084
Calcium edetate, sodium ....................................................... 3807 Carbomers ............................................................................... 2085
Calcium fluoratum for homoeopathic preparations .......... 1707 Carbon dioxide ....................................................................... 2086
Calcium folinate hydrate........................................................ 2049 Carbon dioxide in gases (2.5.24.) ........................................... 174
Calcium glucoheptonate ........................................................ 2051 Carbon monoxide................................................................... 2088
Calcium gluconate .................................................................. 2052 Carbon monoxide (15O) ......................................................... 1184
Calcium gluconate, anhydrous.............................................. 2052 Carbon monoxide in gases (2.5.25.)....................................... 175
Calcium gluconate for injection ........................................... 2053 Carbon monoxide intermix (5 per cent) in nitrogen ......... 2089
Calcium glycerophosphate .................................................... 2054 Carboplatin.............................................................................. 2089
Calcium hydrogen phosphate ............................................... 2055 Carboprost trometamol ......................................................... 2090
Calcium hydrogen phosphate dihydrate.............................. 2056 Carboxymethylcellulose......................................................... 2092
Calcium hydroxide ................................................................. 2057 Carboxymethylcellulose calcium .......................................... 2093
Calcium in adsorbed vaccines (2.5.14.) ................................. 172 Carboxymethylcellulose sodium........................................... 2093
Calcium iodatum for homoeopathic preparations ............. 1708 Carboxymethylcellulose sodium, cross-linked ................... 2318
Calcium iodide tetrahydrate for homoeopathic Carboxymethylcellulose sodium, low-substituted.............. 2094
preparations .......................................................................... 1708 Carisoprodol............................................................................ 2091
Calcium lactate........................................................................ 2058 Carmellose............................................................................... 2092
Calcium lactate monohydrate ............................................... 2058 Carmellose calcium ................................................................ 2093
Calcium lactate pentahydrate................................................ 2059 Carmellose sodium................................................................. 2093
Calcium lactate trihydrate ..................................................... 2059 Carmellose sodium and microcrystalline cellulose............ 3269
Calcium levofolinate hydrate ................................................ 2060 Carmellose sodium, low-substituted.................................... 2094
Calcium levulinate dihydrate ................................................ 2062 Carmustine .............................................................................. 2095
Calcium pantothenate ............................................................ 2063 Carnauba wax.......................................................................... 2096
Calcium pentetate (sodium) for radiopharmaceutical Carprofen for veterinary use ................................................. 2097
preparations .......................................................................... 1223 Carrageenan ............................................................................ 2098
Calcium phosphate................................................................. 2065 Carrier proteins for the production of conjugated
Calcium stearate ..................................................................... 2065 polysaccharide vaccines for human use (5.2.11.) ............... 674
Calcium sulfate dihydrate...................................................... 2067 Carteolol hydrochloride......................................................... 2099
Calendula flower..................................................................... 1368 Carvedilol ................................................................................ 2101
Calf coronavirus diarrhoea vaccine (inactivated)............... 1077 Cascara..................................................................................... 1378
Calf rotavirus diarrhoea vaccine (inactivated).................... 1078 Cascara dry extract, standardised......................................... 1380
Calicivirosis vaccine (inactivated), feline ............................ 1106 Cassia oil .................................................................................. 1381
Calicivirosis vaccine (live), feline ......................................... 1107 Castor oil, hydrogenated........................................................ 2102
Camphor, D-............................................................................ 2067 Castor oil, polyoxyl................................................................. 3144
Camphor, racemic .................................................................. 2069 Castor oil, polyoxyl hydrogenated........................................ 3144
Candesartan cilexetil .............................................................. 2070 Castor oil, refined ................................................................... 2103
Canine adenovirus vaccine (inactivated)............................. 1079 Castor oil, virgin ..................................................................... 2104
Canine adenovirus vaccine (live).......................................... 1080 Catgut, sterile .......................................................................... 1269
Canine distemper vaccine (live) ........................................... 1081 Catgut, sterile, in distributor for veterinary use ................. 1281
Canine leptospirosis vaccine (inactivated) .......................... 1082 CD34/CD45+ cells in haematopoietic products, numeration
Canine parainfluenza virus vaccine (live) ........................... 1084 of (2.7.23.)................................................................................ 292
Canine parvovirosis vaccine (inactivated)........................... 1085 Cefaclor.................................................................................... 2105
Canine parvovirosis vaccine (live)........................................ 1086 Cefadroxil monohydrate........................................................ 2106
Cape aloes................................................................................ 1302 Cefalexin monohydrate.......................................................... 2108
Cape jasmine fruit .................................................................. 1369 Cefalotin sodium .................................................................... 2109
Capecitabine............................................................................ 2072 Cefamandole nafate................................................................ 2111
Capillary electrophoresis (2.2.47.) ............................................ 87 Cefapirin sodium.................................................................... 2112
Capillary viscometer method (2.2.9.)....................................... 27 Cefatrizine propylene glycol.................................................. 2113
Caprylate, sodium................................................................... 3808 Cefazolin sodium.................................................................... 2114
Caprylic acid ........................................................................... 2073 Cefepime dihydrochloride monohydrate ............................ 2117
Caprylocaproyl macrogolglycerides ..................................... 2074 Cefixime................................................................................... 2119
Capsicum ................................................................................. 1371 Cefoperazone sodium ............................................................ 2120
Capsicum oleoresin, refined and standardised ................... 1373 Cefotaxime sodium ................................................................ 2122
Capsicum soft extract, standardised .................................... 1374 Cefoxitin sodium .................................................................... 2124
Capsicum tincture, standardised .......................................... 1375 Cefpodoxime proxetil ............................................................ 2126
Capsules ..................................................................................... 906 Cefprozil monohydrate .......................................................... 2128
Capsules and tablets, disintegration of (2.9.1.) ..................... 323 Cefradine ................................................................................. 2130
Capsules, gastro-resistant ........................................................ 907 Ceftazidime pentahydrate...................................................... 2132
Capsules, hard ........................................................................... 906 Ceftazidime pentahydrate with sodium carbonate for
Capsules, intrauterine .............................................................. 914 injection ................................................................................. 2134
Capsules, modified-release ...................................................... 907 Ceftriaxone sodium................................................................ 2136
Capsules, oromucosal............................................................... 922 Cefuroxime axetil ................................................................... 2138
Capsules, rectal ......................................................................... 934 Cefuroxime sodium................................................................ 2139
Capsules, soft............................................................................. 906 Celandine, greater................................................................... 1463
Capsules, vaginal....................................................................... 941 Celecoxib ................................................................................. 2141

Celiprolol hydrochloride ....................................................... 2142 Chlorphenamine maleate ...................................................... 2187

Cell count and viability, nucleated (2.7.29.).......................... 297 Chlorpromazine hydrochloride ............................................ 2188
Cell cultures for the production of veterinary vaccines Chlorprothixene hydrochloride ............................................ 2189
(5.2.4.) ...................................................................................... 654 Chlortalidone .......................................................................... 2191
Cell substrates for the production of vaccines for human use Chlortetracycline hydrochloride........................................... 2193
(5.2.3.) ...................................................................................... 650 Cholecalciferol ........................................................................ 2195
Cell-based and gene therapy medicinal products, raw materials Cholecalciferol concentrate (oily form)............................... 2197
of biological origin for the production of (5.2.12.) ............ 675 Cholecalciferol concentrate (powder form) ........................ 2198
Cell-based preparations, microbiological examination of Cholecalciferol concentrate (water-dispersible form)........ 2199
(2.6.27.) .................................................................................... 231 Cholera vaccine (inactivated), fowl ...................................... 1117
Cellulose acetate ..................................................................... 2143 Cholera vaccine (inactivated, oral)......................................... 951
Cellulose acetate butyrate ...................................................... 2144 Cholesterol............................................................................... 2201
Cellulose acetate phthalate .................................................... 2145 Cholesterol for parenteral use ............................................... 2202
Cellulose, microcrystalline .................................................... 2146 Cholesterol in oils rich in omega-3 acids, total (2.4.32.) ..... 163
Cellulose (microcrystalline) and carmellose sodium......... 3269 Choline ([11C]methyl) injection............................................ 1185
Cellulose, powdered ............................................................... 2150 Chondroitin sulfate sodium .................................................. 2203
Centaury .................................................................................. 1382 Chromatographic separation techniques (2.2.46.) ................. 80
Centella .................................................................................... 1383 Chromatography, gas (2.2.28.).................................................. 48
Cetirizine dihydrochloride .................................................... 2153 Chromatography, liquid (2.2.29.) ............................................. 49
Cetostearyl alcohol ................................................................. 2155 Chromatography, paper (2.2.26.) ............................................. 46
Cetostearyl alcohol (type A), emulsifying ........................... 2156 Chromatography, size-exclusion (2.2.30.) ............................... 51
Cetostearyl alcohol (type B), emulsifying ........................... 2157 Chromatography, supercritical fluid (2.2.45.)......................... 80
Cetostearyl isononanoate ...................................................... 2159 Chromatography, thin-layer (2.2.27.) ...................................... 47
Cetostearyl sulfate, sodium ................................................... 3810 Chromium (51Cr) edetate injection ...................................... 1186
Cetrimide................................................................................. 2159 Chymotrypsin ......................................................................... 2205
Cetyl alcohol............................................................................ 2160 Ciclesonide .............................................................................. 2206
Cetyl palmitate ........................................................................ 2160 Ciclopirox ................................................................................ 2208
Cetylpyridinium chloride ...................................................... 2161 Ciclopirox olamine ................................................................. 2209
Ceylon cinnamon bark oil..................................................... 1391 Ciclosporin .............................................................................. 2210
Ceylon cinnamon leaf oil....................................................... 1391 Cilastatin sodium.................................................................... 2212
CFC assay for human haematopoietic progenitor cells Cilazapril.................................................................................. 2214
(2.7.28.) .................................................................................... 296 Cimetidine ............................................................................... 2215
Chamomile flower, Roman ................................................... 1384 Cimetidine hydrochloride ..................................................... 2217
Characterisation of crystalline and partially crystalline solids Cinchocaine hydrochloride ................................................... 2218
by X-ray powder diffraction (XRPD) (2.9.33.) ................... 379 Cinchona bark......................................................................... 1387
Characterisation of crystalline solids by microcalorimetry and Cinchona liquid extract, standardised ................................. 1389
solution calorimetry (2.2.61.)................................................ 115 Cineole ..................................................................................... 2220
Characterisation of preparations for nebulisation (2.9.44.).. 404 Cineole in essential oils, 1,8-, assay of (2.8.11.) .................... 307
Characters section in monographs (5.11.) ............................ 769 Cineole type niaouli oil.......................................................... 1554
Charcoal, activated ................................................................. 2162 Cinnamon................................................................................ 1390
Chemical imaging (5.24.) ........................................................ 847 Cinnamon bark oil, Ceylon................................................... 1391
Chemical precursors for radiopharmaceutical Cinnamon leaf oil, Ceylon..................................................... 1391
preparations ............................................................................ 863 Cinnarizine.............................................................................. 2221
Chemometric methods applied to analytical data (5.21.) ... 819 Ciprofibrate ............................................................................. 2222
Chenodeoxycholic acid ......................................................... 2163 Ciprofloxacin........................................................................... 2223
Chewable tablets ....................................................................... 939 Ciprofloxacin hydrochloride ................................................. 2225
Chewing gums, medicated ...................................................... 907 Circular dichroism (2.2.41.) ...................................................... 75
Chewing gums, medicated, dissolution test for (2.9.25.)..... 365 Cisatracurium besilate ........................................................... 2226
Chicken anaemia vaccine (live), infectious ......................... 1122 Cisplatin................................................................................... 2231
Chicken flocks free from specified pathogens for the Citalopram hydrobromide..................................................... 2232
production and quality control of vaccines (5.2.2.) ........... 647 Citalopram hydrochloride ..................................................... 2234
Chinese goldthread rhizome ................................................. 1386 Citric acid ................................................................................ 2235
Chitosan hydrochloride ......................................................... 2164 Citric acid monohydrate ........................................................ 2236
Chlamydiosis vaccine (inactivated), feline ......................... 1108 Citronella oil............................................................................ 1392
Chloral hydrate ....................................................................... 2165 Cladribine ................................................................................ 2237
Chlorambucil .......................................................................... 2166 Clarithromycin........................................................................ 2238
Chloramine.............................................................................. 4074 Clarity and degree of opalescence of liquids (2.2.1.).............. 21
Chloramphenicol .................................................................... 2167 Clary sage oil ........................................................................... 1393
Chloramphenicol palmitate................................................... 2168 Classical swine-fever vaccine (live, prepared in cell
Chloramphenicol sodium succinate..................................... 2170 cultures) ................................................................................. 1159
Chlorcyclizine hydrochloride................................................ 2171 Clazuril for veterinary use..................................................... 2241
Chlordiazepoxide.................................................................... 2172 Clebopride malate .................................................................. 2243
Chlordiazepoxide hydrochloride .......................................... 2173 Clemastine fumarate .............................................................. 2244
Chlorhexidine diacetate ......................................................... 2174 Clematis armandii stem ......................................................... 1394
Chlorhexidine digluconate solution ..................................... 2176 Clenbuterol hydrochloride .................................................... 2246
Chlorhexidine dihydrochloride ............................................ 2178 Clindamycin hydrochloride .................................................. 2247
Chlorides (2.4.4.) ...................................................................... 138 Clindamycin phosphate ......................................................... 2248
Chlormadinone acetate.......................................................... 2180 Clioquinol................................................................................ 2251
Chlorobutanol ......................................................................... 2182 Clobazam ................................................................................. 2252
Chlorobutanol hemihydrate .................................................. 2183 Clobetasol propionate ............................................................ 2253
Chlorocresol ............................................................................ 2184 Clobetasone butyrate.............................................................. 2255
Chloroquine phosphate ......................................................... 2185 Clodronate disodium tetrahydrate ....................................... 2257
Chloroquine sulfate ................................................................ 2186 Clofazimine ............................................................................. 2258
Clofibrate ................................................................................. 2259 Colistin sulfate ........................................................................ 2309

Clomifene citrate .................................................................... 2260 Colloidal anhydrous silica ..................................................... 3787
Clomipramine hydrochloride ............................................... 2261 Colloidal hydrated silica ........................................................ 3788
Clonazepam............................................................................. 2263 Colloidal silica, hydrophobic ................................................ 3789
Clonidine hydrochloride........................................................ 2264 Colloidal silver, for external use ........................................... 3790
Clopamide ............................................................................... 2265 Colony-forming cell assay for human haematopoietic
Clopidogrel besilate................................................................ 2267 progenitor cells (2.7.28.) ........................................................ 296
Clopidogrel hydrochloride .................................................... 2268 Colophony ............................................................................... 1401
Clopidogrel hydrogen sulfate ................................................ 2270 Coloration of liquids (2.2.2.) ..................................................... 22
Clorazepate, dipotassium monohydrate .............................. 2439 Common selfheal fruit-spike ................................................ 1401
Closantel sodium dihydrate for veterinary use................... 2272 Common stinging nettle for homoeopathic preparations.. 1728
Clostridium botulinum vaccine for veterinary use ............ 1087 Comparative table of porosity of sintered-glass filters
Clostridium chauvoei vaccine for veterinary use ............... 1088 (2.1.2.) ........................................................................................ 15
Clostridium novyi (type B) vaccine for veterinary use...... 1088 Complexometric titrations (2.5.11.) ....................................... 170
Clostridium perfringens vaccine for veterinary use........... 1090 Composition of fatty acids by gas chromatography
Clostridium septicum vaccine for veterinary use............... 1092 (2.4.22.) .................................................................................... 147
Closures and containers for parenteral preparations and Composition of fatty acids in oils rich in omega-3 acids
ophthalmic preparations, polypropylene for (3.1.6.) ......... 431 (2.4.29.) .................................................................................... 161
Closures and containers for pharmaceutical use, plastic Compressed lozenges ............................................................... 922
(3.2.2.) ...................................................................................... 459 Concentrated solutions for haemodialysis .......................... 2798
Closures and tubing, silicone elastomer for (3.1.9.)............. 436 Concentrated solutions for haemofiltration and
Closures for containers for aqueous parenteral preparations, haemodiafiltration ................................................................ 2801
for powders and for freeze-dried powders, rubber Concentrates for injections or infusions................................ 924
(3.2.9.) ...................................................................................... 460 Concentrates for intrauterine solutions ................................. 914
Clotrimazole............................................................................ 2273 Conductivity (2.2.38.) ................................................................ 66
Clove......................................................................................... 1396 Coneflower herb, purple ........................................................ 1589
Clove oil ................................................................................... 1396 Coneflower root, narrow-leaved ........................................... 1548
Cloxacillin sodium ................................................................. 2275 Coneflower root, pale............................................................. 1568
Clozapine ................................................................................. 2276 Coneflower root, purple......................................................... 1591
Coagulation factor II, human, assay of (2.7.18.)................... 288 Conjugated estrogens ............................................................. 2561
Coagulation factor IX, human .............................................. 2846 Conjugated polysaccharide vaccines for human use, carrier
Coagulation factor IX, human, assay of (2.7.11.) ................. 281 proteins for the production of (5.2.11.) ............................... 674
Coagulation factor IX (rDNA) concentrated solution, Consistency by penetrometry, measurement of (2.9.9.)...... 337
human .................................................................................... 2848 Containers (3.2.) ....................................................................... 453
Coagulation factor IX (rDNA) powder for solution for Containers and closures for parenteral preparations and
injection, human................................................................... 2853 ophthalmic preparations, polypropylene for (3.1.6.) ......... 431
Coagulation factor VII, human ............................................ 2838 Containers and closures for pharmaceutical use, plastic
Coagulation factor VII, human, assay of (2.7.10.)................ 280 (3.2.2.) ...................................................................................... 459
Coagulation factor VIIa (rDNA) concentrated solution, Containers and tubing for total parenteral nutrition
human .................................................................................... 2840 preparations, poly(ethylene - vinyl acetate) for (3.1.7.)..... 434
Coagulation factor VIII, human ........................................... 2844 Containers for aqueous solutions for infusion, plastic
Coagulation factor VIII, human, assay of (2.7.4.) ................ 268 (3.2.2.1.) ................................................................................... 460
Coagulation factor VIII (rDNA), human ............................ 2845 Containers for aqueous solutions for intravenous infusion,
Coagulation factor X, assay of (2.7.19.) ................................. 289 materials based on, plasticised poly(vinyl chloride) for
Coagulation factor XI, human .............................................. 2855 (3.1.14.) .................................................................................... 445
Coagulation factor XI, human, assay of (2.7.22.) ................. 291 Containers for human blood and blood components, and
Coagulation factors, activated (2.6.22.) ................................. 224 materials used in their manufacture; transfusion sets and
Coagulation factors, assay of heparin (2.7.12.) ..................... 281 materials used in their manufacture; syringes (3.3.).......... 463
Coated granules ........................................................................ 912 Containers for human blood and blood components, materials
Coated tablets............................................................................ 938 based on plasticised poly(vinyl chloride) for (3.3.2.)......... 465
Cocaine hydrochloride........................................................... 2278 Containers for human blood and blood components, materials
Coccidiosis vaccine (live) for chickens ................................ 1094 for (3.3.1.) ................................................................................ 465
Cocculus for homoeopathic preparations ........................... 1708 Containers for human blood and blood components, plastic,
Cocoa butter............................................................................ 2279 sterile (3.3.4.)........................................................................... 471
Coconut oil, refined................................................................ 2279 Containers for non-injectable aqueous solutions, materials
Cocoyl caprylocaprate............................................................ 2280 based on non-plasticised poly(vinyl chloride) for
Codeine hydrochloride dihydrate......................................... 2281 (3.1.10.) .................................................................................... 437
Codeine monohydrate............................................................ 2283 Containers for parenteral preparations and for ophthalmic
Codeine phosphate hemihydrate .......................................... 2285 preparations, polyethylene with additives for (3.1.5.)........ 427
Codeine phosphate sesquihydrate ........................................ 2288 Containers for parenteral preparations and for ophthalmic
Codergocrine mesilate ........................................................... 2290 preparations, polyethylene without additives for (3.1.4.).. 426
Cod-liver oil, farmed.............................................................. 2291 Containers for pharmaceutical use, glass (3.2.1.) ................. 453
Cod-liver oil (type A)............................................................. 2295 Containers for preparations not for parenteral use,
Cod-liver oil (type B) ............................................................. 2299 polyethylene terephthalate for (3.1.15) ................................ 448
Codonopsis root ..................................................................... 1397 Containers for solid dosage forms for oral administration,
Coix seed.................................................................................. 1398 materials based on non-plasticised poly(vinyl chloride) for
Cola .......................................................................................... 1400 (3.1.11.) .................................................................................... 439
Colchicine................................................................................ 2303 Containers, materials used for the manufacture of (3.1.).... 423
Cold-water vibriosis vaccine (inactivated) for salmonids.. 1163 Containers of plasticised poly(vinyl chloride) for human blood
Colestyramine ......................................................................... 2305 and blood components, empty sterile (3.3.5.)..................... 473
Colibacillosis vaccine (inactivated), neonatal piglet .......... 1132 Containers of plasticised poly(vinyl chloride) for human blood
Colibacillosis vaccine (inactivated), neonatal ruminant.... 1133 containing anticoagulant solution, sterile (3.3.6.) .............. 474
Colistimethate sodium........................................................... 2306

Contamination, microbial : microbial enumeration tests Cytarabine ............................................................................... 2332

(2.6.12.) .................................................................................... 201
Contamination, microbial : microbial enumeration tests (live D
biotherapeutic products) (2.6.36.) ........................................ 250 Dacarbazine............................................................................. 2337
Contamination, microbial : test for specified micro-organisms Dalteparin sodium.................................................................. 2338
(2.6.13.) .................................................................................... 205 Danaparoid sodium................................................................ 2340
Contamination, microbial : tests for specified micro-organisms Dandelion herb with root ...................................................... 1408
(live biotherapeutic products) (2.6.38.) ............................... 255 Dandelion root........................................................................ 1409
Content uniformity of single-dose preparations (2.9.6.) ..... 336 Dapsone ................................................................................... 2342
Control of impurities in substances for pharmaceutical use Daunorubicin hydrochloride ................................................ 2343
(5.10.) ....................................................................................... 763 D-Camphor .............................................................................. 2067
Control of microbiological quality, alternative methods for Decyl oleate ............................................................................. 2344
(5.1.6.) ...................................................................................... 628 Deferiprone ............................................................................. 2344
Copolymer, basic butylated methacrylate ........................... 1925 Deferiprone oral solution ...................................................... 2345
Copolymer, grafted, macrogol poly(vinyl alcohol) ............ 3140 Deferiprone tablets ................................................................. 2346
Copolymer, methacrylic acid - ethyl acrylate (1:1) ............ 3214 Deferoxamine mesilate........................................................... 2347
Copolymer, methacrylic acid - ethyl acrylate (1:1) dispersion Degree of coloration of liquids (2.2.2.) .................................... 22
30 per cent ............................................................................. 3216 Dembrexine hydrochloride monohydrate for veterinary
Copolymer, methacrylic acid – methyl methacrylate use........................................................................................... 2350
(1:1) ........................................................................................ 3217 Demeclocycline hydrochloride ............................................. 2351
Copolymer, methacrylic acid - methyl methacrylate Demonstration of uniformity of dosage units using large
(1:2) ........................................................................................ 3218 sample sizes (2.9.47.).............................................................. 409
Copolymer (type A), ammonio methacrylate..................... 1830 Density of powders, bulk density and tapped (2.9.34.)........ 384
Copolymer (type B), ammonio methacrylate ..................... 1831 Density of solids (2.2.42.) .......................................................... 76
Copovidone ............................................................................. 2311 Density of solids, gas pycnometric (2.9.23.).......................... 364
Copper acetate monohydrate for homoeopathic Density, relative (2.2.5.) ............................................................. 25
preparations .......................................................................... 1711 Dental type silica .................................................................... 3788
Copper for homoeopathic preparations .............................. 1712 Depressor substances (2.6.11.) ................................................ 200
Copper sulfate ......................................................................... 2313 Deptropine citrate................................................................... 2353
Copper sulfate pentahydrate ................................................. 2314 Dequalinium chloride ............................................................ 2354
Copper tetramibi tetrafluoroborate for radiopharmaceutical Desacyl-4′-monophosphoryl lipid A, 3-O- ......................... 2355
preparations .......................................................................... 1187 Desflurane................................................................................ 2357
Coriander................................................................................. 1403 Desipramine hydrochloride................................................... 2358
Coriander oil ........................................................................... 1404 Deslanoside ............................................................................. 2359
Coronavirus diarrhoea vaccine (inactivated), calf ............. 1077 Desloratadine .......................................................................... 2360
Cortisone acetate .................................................................... 2315 Desmopressin .......................................................................... 2361
Corydalis rhizome .................................................................. 1405 Desogestrel .............................................................................. 2363
Cotton, absorbent ................................................................... 2316 Detection and measurement of radioactivity (2.2.66.) ........ 119
Cottonseed oil, hydrogenated .............................................. 2317 Detection, direct amperometric and pulsed electrochemical
Couch grass rhizome.............................................................. 1407 (2.2.63.) .................................................................................... 117
Creams ....................................................................................... 936 Detector tubes, gas (2.1.6.) ........................................................ 17
Cresol, crude ........................................................................... 2318 Determination of aflatoxin B1 in herbal drugs (2.8.18.) ...... 311
Crocus for homoeopathic preparations ............................... 1710 Determination of bactericidal, fungicidal or yeasticidal activity
Cromoglicate, sodium............................................................ 3813 of antiseptic medicinal products (5.1.11.) ........................... 643
Croscarmellose sodium ......................................................... 2318 Determination of elemental impurities (2.4.20.) .................. 144
Crospovidone .......................................................................... 2319 Determination of nitrogen by sulfuric acid digestion
Crotamiton .............................................................................. 2321 (2.5.9.) ...................................................................................... 170
Crystalline and partially crystalline solids, characterisation Determination of primary aromatic amino-nitrogen
by X-ray powder diffraction (XRPD) of (2.9.33.)............... 379 (2.5.8.) ...................................................................................... 169
Crystalline solids, characterisation by microcalorimetry and Determination of water by distillation (2.2.13.) ..................... 31
solution calorimetry (2.2.61.)................................................ 115 Detomidine hydrochloride for veterinary use .................... 2364
Crystallinity (5.16.)................................................................... 797 Devil’s claw dry extract .......................................................... 1410
Cuprum aceticum for homoeopathic preparations............ 1711 Devil’s claw root...................................................................... 1411
Cuprum metallicum for homoeopathic preparations........ 1712 Dexamethasone....................................................................... 2365
Cutaneous application, liquid preparations for .................... 916 Dexamethasone acetate.......................................................... 2367
Cutaneous application, powders for....................................... 925 Dexamethasone isonicotinate ............................................... 2369
Cutaneous application, semi-solid preparations for ............ 935 Dexamethasone sodium phosphate...................................... 2370
Cutaneous application, veterinary liquid preparations for.. 941 Dexamfetamine sulfate .......................................................... 2373
Cutaneous foams ...................................................................... 916 Dexchlorpheniramine maleate.............................................. 2374
Cutaneous patches .................................................................... 935 Dexpanthenol.......................................................................... 2375
Cyanocobalamin ..................................................................... 2322 Dextran 1 for injection........................................................... 2376
Cyanocobalamin (57Co) capsules .......................................... 1188 Dextran 40 for injection ........................................................ 2377
Cyanocobalamin (57Co) solution .......................................... 1188 Dextran 60 for injection ........................................................ 2378
Cyanocobalamin (58Co) capsules .......................................... 1189 Dextran 70 for injection ........................................................ 2379
Cyanocobalamin (58Co) solution .......................................... 1189 Dextranomer ........................................................................... 2380
Cyclamate, sodium ................................................................. 3814 Dextrans, molecular mass distribution in (2.2.39.)................ 68
Cyclizine hydrochloride......................................................... 2323 Dextrin ..................................................................................... 2380
Cyclopentolate hydrochloride ............................................... 2324 Dextromethorphan hydrobromide....................................... 2381
Cyclophosphamide ................................................................. 2326 Dextromoramide tartrate ...................................................... 2382
Cyproheptadine hydrochloride............................................. 2326 Dextropropoxyphene hydrochloride.................................... 2383
Cyproterone acetate................................................................ 2327 Dextrose................................................................................... 2758
Cysteine hydrochloride monohydrate.................................. 2329 Dextrose monohydrate........................................................... 2761
Cystine ..................................................................................... 2331
Diacerein.................................................................................. 2384 Diphtheria, tetanus, pertussis (acellular, component) and

Diazepam................................................................................. 2386 poliomyelitis (inactivated) vaccine (adsorbed, reduced
Diazoxide ................................................................................. 2388 antigen(s) content) ................................................................. 966
Dibrompropamidine diisetionate ......................................... 2388 Diphtheria, tetanus, pertussis (acellular, component),
Dibutyl phthalate .................................................................... 2389 hepatitis B (rDNA), poliomyelitis (inactivated) and
Dichlorobenzyl alcohol, 2,4- ................................................. 2390 haemophilus type b conjugate vaccine (adsorbed) ............ 968
Dichloromethane .................................................................... 3235 Diphtheria, tetanus, pertussis (acellular, component),
Diclazuril for veterinary use.................................................. 2391 poliomyelitis (inactivated) and haemophilus type b conjugate
Diclofenac potassium ............................................................. 2393 vaccine (adsorbed) ................................................................. 970
Diclofenac sodium.................................................................. 2394 Diphtheria, tetanus, pertussis (whole cell) and poliomyelitis
Dicloxacillin sodium .............................................................. 2396 (inactivated) vaccine (adsorbed) .......................................... 973
Dicyclomine hydrochloride................................................... 2397 Diphtheria, tetanus, pertussis (whole cell), poliomyelitis
Dicycloverine hydrochloride................................................. 2397 (inactivated) and haemophilus type b conjugate vaccine
Didanosine .............................................................................. 2398 (adsorbed) ............................................................................... 974
Dienogest ................................................................................. 2400 Diphtheria vaccine (adsorbed)................................................ 977
Diethyl phthalate .................................................................... 2402 Diphtheria vaccine (adsorbed), assay of (2.7.6.)................... 269
Diethylcarbamazine citrate.................................................... 2403 Diphtheria vaccine (adsorbed, reduced antigen content) ... 978
Diethylene glycol and ethylene glycol in ethoxylated Dipivefrine hydrochloride ..................................................... 2437
substances (2.4.30.)................................................................. 163 Dipotassium clorazepate monohydrate ............................... 2439
Diethylene glycol monoethyl ether ...................................... 2404 Dipotassium phosphate ......................................................... 2440
Diethylene glycol palmitostearate......................................... 2405 Diprophylline .......................................................................... 2441
Diethylstilbestrol..................................................................... 2406 Dipyridamole .......................................................................... 2442
Diffraction, laser light, particle size analysis by (2.9.31.) ... 373 Direct amperometric and pulsed electrochemical detection
Difloxacin hydrochloride trihydrate for veterinary use..... 2407 (2.2.63.) .................................................................................... 117
Digitalis for homoeopathic preparations............................. 1712 Dirithromycin ......................................................................... 2444
Digitalis leaf............................................................................. 1412 Disintegration of suppositories and pessaries (2.9.2.) ......... 325
Digitoxin .................................................................................. 2409 Disintegration of tablets and capsules (2.9.1.) ...................... 323
Digoxin .................................................................................... 2410 Disodium clodronate tetrahydrate ....................................... 2257
Dihydralazine sulfate, hydrated ............................................ 2413 Disodium edetate.................................................................... 2445
Dihydrocodeine hydrogen tartrate ....................................... 2414 Disodium etidronate .............................................................. 2589
Dihydroergocristine mesilate ................................................ 2415 Disodium pamidronate pentahydrate .................................. 3474
Dihydroergotamine mesilate................................................. 2418 Disodium phosphate .............................................................. 2446
Dihydrostreptomycin sulfate for veterinary use ................. 2420 Disodium phosphate dihydrate............................................. 2447
Dihydrotachysterol ................................................................. 2422 Disodium phosphate dodecahydrate.................................... 2447
Diltiazem hydrochloride........................................................ 2423 Disopyramide.......................................................................... 2448
Dimenhydrinate...................................................................... 2425 Disopyramide phosphate ....................................................... 2449
Dimercaprol ............................................................................ 2426 Dispersible tablets..................................................................... 939
Dimethyl sulfoxide ................................................................. 2427 Dissolution, apparent (2.9.43.)................................................ 403
Dimethylacetamide ................................................................ 2428 Dissolution, intrinsic (2.9.29.) ................................................ 372
Dimethylaniline, N,N- (2.4.26.) .............................................. 158 Dissolution test for lipophilic solid dosage forms (2.9.42.).. 401
Dimeticone .............................................................................. 2429 Dissolution test for medicated chewing gums (2.9.25.)....... 365
Dimetindene maleate ............................................................. 2429 Dissolution test for solid dosage forms (2.9.3.) .................... 326
Dinoprost trometamol ........................................................... 2431 Dissolution test for transdermal patches (2.9.4.).................. 333
Dinoprostone .......................................................................... 2432 Dissolution testing, recommendations on (5.17.1.) ............. 801
Dioscorea nipponica rhizome ............................................... 1413 Distemper vaccine (live), canine........................................... 1081
Dioscorea oppositifolia rhizome........................................... 1414 Distemper vaccine (live) for mustelids ................................ 1097
Diosmin ................................................................................... 2433 Distillation range (2.2.11.)......................................................... 30
Dioxan and ethylene oxide (2.4.25.)....................................... 157 Distribution estimation by analytical sieving, particle-size
Dip concentrates ....................................................................... 942 (2.9.38.) .................................................................................... 392
Diphenhydramine hydrochloride ......................................... 2435 Disulfiram................................................................................ 2450
Diphenoxylate hydrochloride................................................ 2436 Dithranol ................................................................................. 2451
Diphtheria and tetanus toxins and toxoids, flocculation value DL-Methionine ........................................................................ 3225
(Lf) of, (Ramon assay) (2.7.27.)............................................ 295 DL-α-Tocopheryl hydrogen succinate................................... 4062
Diphtheria and tetanus vaccine (adsorbed) .......................... 952 DNA, residual host-cell, quantification and characterisation of
Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) (2.6.35.) .................................................................................... 248
content).................................................................................... 953 Dobesilate monohydrate, calcium ........................................ 2048
Diphtheria antitoxin............................................................... 1170 Dobutamine hydrochloride ................................................... 2452
Diphtheria, tetanus and hepatitis B (rDNA) vaccine Docetaxel ................................................................................. 2453
(adsorbed) ............................................................................... 954 Docetaxel trihydrate ............................................................... 2455
Diphtheria, tetanus and pertussis (acellular, component) Docusate sodium .................................................................... 2457
vaccine (adsorbed) ................................................................. 955 Dodecyl gallate........................................................................ 2457
Diphtheria, tetanus and pertussis (acellular, component) Dog rose................................................................................... 1415
vaccine (adsorbed, reduced antigen(s) content)................. 956 Domperidone .......................................................................... 2458
Diphtheria, tetanus and pertussis (whole cell) vaccine Domperidone maleate............................................................ 2460
(adsorbed) ............................................................................... 958 Dopamine hydrochloride ...................................................... 2461
Diphtheria, tetanus and poliomyelitis (inactivated) vaccine Dopexamine dihydrochloride ............................................... 2463
(adsorbed, reduced antigen(s) content)............................... 959 Dorzolamide hydrochloride .................................................. 2464
Diphtheria, tetanus, pertussis (acellular, component) and Dosage forms (glossary) .......................................................... 905
haemophilus type b conjugate vaccine (adsorbed) ............ 961 Dosage units, demonstration of uniformity using large sample
Diphtheria, tetanus, pertussis (acellular, component) and sizes (2.9.47.) ........................................................................... 409
hepatitis B (rDNA) vaccine (adsorbed) ............................... 963 Dosage units, uniformity of (2.9.40.) ..................................... 398
Diphtheria, tetanus, pertussis (acellular, component) and Dosulepin hydrochloride....................................................... 2466
poliomyelitis (inactivated) vaccine (adsorbed)................... 964 DOTATOC (gallium (68Ga)) injection ................................. 1208

Doxapram hydrochloride ...................................................... 2467 Endotoxins, bacterial, guidelines for using the test for
Doxazosin mesilate................................................................. 2468 (5.1.10.) .................................................................................... 639
Doxepin hydrochloride .......................................................... 2470 Enilconazole for veterinary use ............................................ 2500
Doxorubicin hydrochloride................................................... 2471 Enoxaparin sodium ................................................................ 2502
Doxycycline hyclate ................................................................ 2472 Enoxolone ................................................................................ 2504
Doxycycline monohydrate..................................................... 2474 Enrofloxacin for veterinary use............................................. 2505
Doxylamine hydrogen succinate........................................... 2476 Entacapone .............................................................................. 2507
Dronedarone hydrochloride.................................................. 2477 Entecavir monohydrate.......................................................... 2508
Drop point (2.2.17.).................................................................... 33 Enteric redmouth disease vaccine (inactivated) for rainbow
Droperidol ............................................................................... 2478 trout........................................................................................ 1102
Droppers (2.1.1.)......................................................................... 15 Enumeration of microbial contaminants in live biotherapeutic
Drops (nasal) and sprays (liquid nasal) ................................. 919 products (2.6.36.).................................................................... 250
Drops, oral................................................................................. 918 Enzootic pneumonia vaccine (inactivated), porcine.......... 1141
Drospirenone .......................................................................... 2480 Ephedra herb ........................................................................... 1425
Dry extracts ............................................................................... 868 Ephedrine ................................................................................ 2510
Dry residue of extracts (2.8.16.).............................................. 311 Ephedrine hemihydrate ......................................................... 2511
Drying, loss on (2.2.32.)............................................................. 57 Ephedrine hydrochloride....................................................... 2511
Drynaria rhizome ................................................................... 1416 Ephedrine hydrochloride, racemic ....................................... 2513
Duck plague vaccine (live)..................................................... 1098 Epinastine hydrochloride....................................................... 2513
Duck viral hepatitis type I vaccine (live) ............................. 1099 Epinephrine ............................................................................. 1766
Duloxetine hydrochloride...................................................... 2481 Epinephrine tartrate ............................................................... 1767
Dutasteride .............................................................................. 2483 Epirubicin hydrochloride ...................................................... 2514
Dwarf lilyturf tuber ................................................................ 1418 Eplerenone............................................................................... 2516
Dwarf pine oil ......................................................................... 1419 Eptacog alfa (activated) concentrated solution................... 2840
Dydrogesterone....................................................................... 2485 Equine herpesvirus vaccine (inactivated)............................ 1103
Equine influenza vaccine (inactivated) ................................ 1104
E Equisetum stem ...................................................................... 1426
Ear drops and ear sprays.......................................................... 908 Ergocalciferol .......................................................................... 2518
Ear powders............................................................................... 909 Ergoloid mesilates................................................................... 2290
Ear preparations........................................................................ 908 Ergometrine maleate .............................................................. 2520
Ear preparations, semi-solid ................................................... 908 Ergotamine tartrate ................................................................ 2521
Ear sprays and ear drops.......................................................... 908 Erysipelas vaccine (inactivated), swine................................ 1158
Ear tampons .............................................................................. 909 Erythritol ................................................................................. 2522
Ear washes ................................................................................. 909 Erythromycin .......................................................................... 2524
Ebastine.................................................................................... 2489 Erythromycin estolate ............................................................ 2527
Eclipta herb ............................................................................. 1420 Erythromycin ethylsuccinate................................................. 2531
Econazole................................................................................. 2490 Erythromycin lactobionate .................................................... 2533
Econazole nitrate .................................................................... 2491 Erythromycin stearate............................................................ 2537
Edetate (chromium (51Cr)) injection.................................... 1186 Erythropoietin concentrated solution.................................. 2540
Edetate, disodium ................................................................... 2445 Escitalopram............................................................................ 2544
Edetate, sodium calcium........................................................ 3807 Escitalopram oxalate .............................................................. 2546
Edetic acid ............................................................................... 2492 Eserine salicylate..................................................................... 3554
Edotreotide (gallium (68Ga)) injection................................. 1208 Esketamine hydrochloride..................................................... 2548
Edrophonium chloride........................................................... 2493 Esomeprazole magnesium dihydrate ................................... 2549
Effervescent granules ............................................................... 912 Esomeprazole magnesium trihydrate................................... 2551
Effervescent powders ............................................................... 927 Esomeprazole sodium ............................................................ 2553
Effervescent tablets................................................................... 939 Essential oils .............................................................................. 864
Efficacy of antimicrobial preservation (5.1.3.)...................... 625 Essential oils, assay of 1,8-cineole in (2.8.11.)....................... 307
Efficacy of veterinary vaccines and immunosera, evaluation of Essential oils, fatty oils and resinified essential oils in
(5.2.7.) ...................................................................................... 661 (2.8.7.) ...................................................................................... 306
Egg drop syndrome ′76 vaccine (inactivated) ..................... 1100 Essential oils, foreign esters in (2.8.6.)................................... 306
Egg phospholipids for injection............................................ 2494 Essential oils in herbal drugs (2.8.12.) ................................... 307
Elder flower ............................................................................. 1421 Essential oils, odour and taste (2.8.8.) ................................... 306
Electrochemical detection, pulsed, and direct amperometric Essential oils, residue on evaporation (2.8.9.)....................... 306
detection (2.2.63.)................................................................... 117 Essential oils, solubility in alcohol (2.8.10.) .......................... 306
Electrophoresis (2.2.31.) ............................................................ 51 Essential oils, water in (2.8.5.)................................................. 306
Electrophoresis, capillary (2.2.47.) ........................................... 87 Ester value (2.5.2.) .................................................................... 167
Elemental impurities (5.20.).................................................... 815 Estradiol benzoate .................................................................. 2555
Elemental impurities, determination of (2.4.20.) ................. 144 Estradiol hemihydrate............................................................ 2556
Eleutherococcus...................................................................... 1423 Estradiol valerate .................................................................... 2557
Emedastine difumarate .......................................................... 2496 Estriol ....................................................................................... 2559
Empty sterile containers of plasticised poly(vinyl chloride) for Estrogens, conjugated............................................................. 2561
human blood and blood components (3.3.5.)..................... 473 Etacrynic acid.......................................................................... 2563
Emulsifying cetostearyl alcohol (type A)............................. 2156 Etamsylate................................................................................ 2565
Emulsifying cetostearyl alcohol (type B) ............................. 2157 Etanercept ................................................................................ 2566
Emulsions, solutions and suspensions, oral .......................... 917 Ethacridine lactate monohydrate.......................................... 2570
Enalapril maleate .................................................................... 2497 Ethambutol hydrochloride .................................................... 2571
Enalaprilat dihydrate.............................................................. 2499 Ethanol (96 per cent).............................................................. 2573
Encephalitis vaccine (inactivated), tick-borne.................... 1043 Ethanol, anhydrous................................................................. 2575
Encephalomyelitis vaccine (live), infectious, avian ............ 1065 Ethanol content (2.9.10.) ......................................................... 339
Endotoxins, bacterial (2.6.14.) ................................................ 209 Ether ......................................................................................... 2577
Ether, anaesthetic.................................................................... 2577
Ethinylestradiol ....................................................................... 2578
Ethionamide ............................................................................ 2580 F

Ethosuximide .......................................................................... 2581 F0 concept to steam sterilisation of aqueous preparations,
Ethoxylated substances, ethylene glycol and diethylene glycol application of (5.1.5.) ............................................................. 628
in (2.4.30.) ............................................................................... 163 Factor II, human coagulation, assay of (2.7.18.)................... 288
Ethyl acetate ............................................................................ 2582 Factor IX, human coagulation .............................................. 2846
Ethyl acrylate - methacrylic acid copolymer (1:1).............. 3214 Factor IX, human coagulation, assay of (2.7.11.) ................. 281
Ethyl acrylate - methacrylic acid copolymer (1:1) dispersion Factor IX (rDNA) concentrated solution, human
30 per cent ............................................................................. 3216 coagulation ............................................................................ 2848
Ethyl oleate .............................................................................. 2583 Factor IX (rDNA) powder for solution for injection, human
Ethyl parahydroxybenzoate ................................................... 2583 coagulation ............................................................................ 2853
Ethyl parahydroxybenzoate sodium..................................... 3816 Factor VII, human coagulation............................................. 2838
Ethylcellulose........................................................................... 2585 Factor VII, human coagulation, assay of (2.7.10.)................ 280
Ethylene glycol and diethylene glycol in ethoxylated substances Factor VIIa (rDNA) concentrated solution, human coagulation
(2.4.30.) .................................................................................... 163 ................................................................................................ 2840
Ethylene glycol monopalmitostearate .................................. 2586 Factor VIII, human coagulation ........................................... 2844
Ethylene glycol monostearate................................................ 2586 Factor VIII, human coagulation, assay of (2.7.4.) ................ 268
Ethylene oxide and dioxan (2.4.25.) ....................................... 157 Factor VIII (rDNA), human coagulation ............................ 2845
Ethylenediamine ..................................................................... 2587 Factor X, human coagulation, assay of (2.7.19.) ................... 289
Ethylhexanoic acid, 2- (2.4.28.)............................................... 160 Factor XI, human coagulation .............................................. 2855
Ethylmorphine hydrochloride............................................... 2587 Factor XI, human coagulation, assay of (2.7.22.) ................. 291
Etidronate disodium............................................................... 2589 Falling ball and automatic rolling ball viscometer methods
Etilefrine hydrochloride......................................................... 2589 (2.2.49.) ...................................................................................... 94
Etodolac ................................................................................... 2591 Famotidine............................................................................... 2609
Etofenamate............................................................................. 2593 Fat, hard ................................................................................... 2811
Etomidate................................................................................. 2595 Fat, hard with additives.......................................................... 2812
Etoposide ................................................................................. 2596 Fatty acids, composition by gas chromatography (2.4.22.).. 147
Eucalyptus leaf ........................................................................ 1428 Fatty acids in oils rich in omega-3 acids, composition of
Eucalyptus oil .......................................................................... 1429 (2.4.29.) .................................................................................... 161
Eucommia bark....................................................................... 1430 Fatty oils, alkaline impurities in (2.4.19.) .............................. 144
Eugenol .................................................................................... 2599 Fatty oils and resinified essential oils in essential oils
European goldenrod............................................................... 1460 (2.8.7.) ...................................................................................... 306
European viper venom antiserum ........................................ 1174 Fatty oils, foreign oils in, by thin-layer chromatography
Evaluation of efficacy of veterinary vaccines and immunosera (2.4.21.) .................................................................................... 147
(5.2.7.) ...................................................................................... 661 Fatty oils, identification by thin-layer chromatography
Evaluation of safety of each batch of immunosera for (2.3.2.) ...................................................................................... 132
veterinary use (5.2.9.)............................................................. 673 Fatty oils, sterols in (2.4.23.).................................................... 150
Evaluation of safety of veterinary vaccines and immunosera Fatty oils, vegetable................................................................... 901
(5.2.6.) ...................................................................................... 658 Fc function of immunoglobulin, test for (2.7.9.).................. 279
Evening primrose oil, refined................................................ 2601 Febantel for veterinary use .................................................... 2610
Everolimus ............................................................................... 2601 Feeding stuffs for veterinary use, medicated, premixes for.. 927
Evodia fruit.............................................................................. 1431 Felbinac .................................................................................... 2611
Excipients, functionality-related characteristics of (5.15.) .. 793 Feline calicivirosis vaccine (inactivated).............................. 1106
Exemestane.............................................................................. 2604 Feline calicivirosis vaccine (live)........................................... 1107
Extemporaneous preparation of radiopharmaceuticals Feline chlamydiosis vaccine (inactivated) ........................... 1108
(5.19.) ....................................................................................... 807 Feline infectious enteritis (feline panleucopenia) vaccine
Extractable volume of parenteral preparations, test for (inactivated) .......................................................................... 1109
(2.9.17.) .................................................................................... 347 Feline infectious enteritis (feline panleucopenia) vaccine
Extracts, dry .............................................................................. 868 (live) ....................................................................................... 1110
Extracts, dry residue of (2.8.16.)............................................. 311 Feline leukaemia vaccine (inactivated) ................................ 1112
Extracts, herbal drug ................................................................ 865 Feline panleucopenia vaccine (inactivated)......................... 1109
Extracts, herbal drug, monographs on (information chapter) Feline panleucopenia vaccine (live) ..................................... 1110
(5.23.) ....................................................................................... 843 Feline viral rhinotracheitis vaccine (inactivated) ............... 1113
Extracts, liquid (fluid) .............................................................. 867 Feline viral rhinotracheitis vaccine (live) ............................ 1114
Extracts, loss on drying of (2.8.17.)........................................ 311 Felodipine ................................................................................ 2612
Extracts, soft.............................................................................. 867 Felypressin ............................................................................... 2614
Extracts used in the preparation of herbal medicinal products Fenbendazole for veterinary use........................................... 2615
for oral use, microbiological examination (2.6.31.) ........... 239 Fenbufen .................................................................................. 2616
Extracts used in the preparation of herbal medicinal products Fennel, bitter ........................................................................... 1433
for oral use, microbiological quality (5.1.8.) ....................... 638 Fennel, sweet ........................................................................... 1434
Extracts, water for preparation of......................................... 4206 Fenofibrate............................................................................... 2617
Extraneous agents in viral vaccines for human use, tests for Fenoterol hydrobromide ........................................................ 2618
(2.6.16.) .................................................................................... 214 Fentanyl.................................................................................... 2619
Extraneous agents : tests in batches of finished product of Fentanyl citrate........................................................................ 2621
avian live virus vaccines (2.6.25.) ......................................... 227 Fenticonazole nitrate .............................................................. 2622
Extraneous agents : tests in seed lots of avian viral vaccines Fenugreek ................................................................................ 1435
(2.6.24.) .................................................................................... 224 Fermentation, products of ....................................................... 882
Eye drops ................................................................................... 909 Ferric chloride hexahydrate................................................... 2624
Eye lotions ................................................................................. 910 Ferrous fumarate..................................................................... 2624
Eye preparations ....................................................................... 909 Ferrous gluconate ................................................................... 2625
Eye preparations, semi-solid ................................................... 910 Ferrous sulfate, dried.............................................................. 2626
Ferrous sulfate heptahydrate ................................................. 2627
Ferrum metallicum for homoeopathic preparations ......... 1714

FET (18F) injection.................................................................. 1201 Folinate hydrate, calcium....................................................... 2049

Feverfew ................................................................................... 1436 Follitropin ................................................................................ 2691
Fexofenadine hydrochloride.................................................. 2628 Follitropin concentrated solution ......................................... 2697
Fibrin sealant kit ..................................................................... 2630 Foot-and-mouth disease (ruminants) vaccine
Fibrinogen, human ................................................................. 2856 (inactivated) .......................................................................... 1115
Filgrastim concentrated solution.......................................... 2631 Foreign esters in essential oils (2.8.6.).................................... 306
Filgrastim injection ................................................................ 2634 Foreign matter (2.8.2.) ............................................................. 305
Films, orodispersible ................................................................ 922 Foreign oils in fatty oils by thin-layer chromatography
Finasteride ............................................................................... 2636 (2.4.21.) .................................................................................... 147
Fineness, powder (2.9.35.) ....................................................... 387 Formaldehyde, free (2.4.18.).................................................... 143
Fingolimod hydrochloride..................................................... 2637 Formaldehyde solution (35 per cent) ................................... 2703
Fipronil for veterinary use..................................................... 2639 Formic acid.............................................................................. 2703
Fish oil, rich in omega-3 acids .............................................. 2639 Formoterol fumarate dihydrate............................................. 2704
Flavoxate hydrochloride......................................................... 2642 Foscarnet sodium hexahydrate ............................................. 2706
Flecainide acetate.................................................................... 2643 Fosfomycin calcium................................................................ 2708
Fleeceflower root..................................................................... 1437 Fosfomycin sodium ................................................................ 2709
Flocculation value (Lf) of diphtheria and tetanus toxins and Fosfomycin trometamol......................................................... 2710
toxoids (Ramon assay) (2.7.27.)............................................ 295 Fosinopril sodium .................................................................. 2711
Flow cytometry (2.7.24.).......................................................... 293 Fourstamen stephania root.................................................... 1438
Flowability (2.9.16.).................................................................. 346 Fowl cholera vaccine (inactivated) ....................................... 1117
FLT (18F) injection .................................................................. 1181 Fowl-pox vaccine (live) .......................................................... 1118
Flubendazole ........................................................................... 2644 Framycetin sulfate .................................................................. 2714
Flucloxacillin magnesium octahydrate ................................ 2645 Frangula bark .......................................................................... 1439
Flucloxacillin sodium ............................................................. 2647 Frangula bark dry extract, standardised .............................. 1441
Fluconazole.............................................................................. 2649 Frankincense, Indian.............................................................. 1480
Flucytosine............................................................................... 2650 Fraxinus rhynchophylla bark ................................................ 1441
Fludarabine phosphate........................................................... 2652 Free formaldehyde (2.4.18.)..................................................... 143
Fludeoxyglucose (18F) injection ............................................ 1190 Freezing point (2.2.18.) .............................................................. 35
Fludrocortisone acetate.......................................................... 2654 Fresh bilberry fruit dry extract, refined and standardised.. 1442
Flumazenil ............................................................................... 2655 Friability of granules and spheroids (2.9.41.)........................ 400
Flumazenil (N-[11C]methyl) injection.................................. 1192 Friability of uncoated tablets (2.9.7.) ..................................... 336
Flumequine.............................................................................. 2657 Fructose.................................................................................... 2715
Flumetasone pivalate.............................................................. 2658 Fucus ........................................................................................ 1494
Flunarizine dihydrochloride.................................................. 2659 Fulvestrant ............................................................................... 2716
Flunitrazepam ......................................................................... 2660 Fumitory .................................................................................. 1444
Flunixin meglumine for veterinary use ............................... 2661 Functional groups and ions, identification reactions of
Fluocinolone acetonide.......................................................... 2662 (2.3.1.) ...................................................................................... 129
Fluocortolone pivalate............................................................ 2665 Functionality-related characteristics of excipients (5.15.) ... 793
Fluorescein .............................................................................. 2666 Fungicidal, bactericidal or yeasticidal activity of antiseptic
Fluorescein sodium ................................................................ 2667 medicinal products, determination of (5.1.11.) .................. 643
Fluoride (18F) solution for radiolabelling............................. 1194 Furosemide .............................................................................. 2718
Fluorides (2.4.5.) ....................................................................... 138 Furunculosis vaccine (inactivated, oil-adjuvanted, injectable)
Fluorimetry (2.2.21.) .................................................................. 36 for salmonids......................................................................... 1119
Fluorocholine (18F) injection................................................. 1195 Fusidate, sodium..................................................................... 3818
Fluorodeoxythymidine (18F) injection ................................. 1181 Fusidic acid.............................................................................. 2719
Fluorodopa (18F) (prepared by electrophilic substitution)
injection ................................................................................. 1197 G
Fluorodopa (18F) (prepared by nucleophilic substitution) Gabapentin .............................................................................. 2725
injection ................................................................................. 1198 Gadobutrol monohydrate ...................................................... 2726
Fluoroethyl-L-tyrosine (18F) injection .................................. 1201 Gadodiamide hydrate............................................................. 2728
Fluoromisonidazole (18F) injection....................................... 1204 Galactose.................................................................................. 2730
Fluorouracil ............................................................................. 2669 Galantamine hydrobromide .................................................. 2731
Fluoxetine hydrochloride....................................................... 2670 Gallium (67Ga) citrate injection ............................................ 1206
Flupentixol dihydrochloride.................................................. 2672 Gallium (68Ga) chloride solution for radiolabelling ........... 1206
Fluphenazine decanoate......................................................... 2674 Gallium (68Ga) DOTATOC injection ................................... 1208
Fluphenazine dihydrochloride .............................................. 2675 Gallium (68Ga) edotreotide injection ................................... 1208
Fluphenazine enantate ........................................................... 2677 Gammacyclodextrin ............................................................... 2734
Flurazepam monohydrochloride .......................................... 2679 Gammadex .............................................................................. 2734
Flurbiprofen............................................................................. 2680 Ganciclovir .............................................................................. 2735
Fluspirilene .............................................................................. 2681 Gargles ....................................................................................... 921
Flutamide................................................................................. 2682 Garlic for homoeopathic preparations................................. 1701
Fluticasone propionate........................................................... 2683 Garlic powder.......................................................................... 1446
Flutrimazole ............................................................................ 2685 Gas adsorption, specific surface area by (2.9.26.)................. 369
Fluvastatin sodium ................................................................. 2686 Gas chromatography (2.2.28.)................................................... 48
Fluvoxamine maleate.............................................................. 2688 Gas detector tubes (2.1.6.) ......................................................... 17
FMISO (18F) injection ............................................................ 1204 Gas pycnometric density of solids (2.9.23.)........................... 364
Foam index (2.8.24.)................................................................. 317 Gases, carbon dioxide in (2.5.24.) .......................................... 174
Foams, cutaneous ..................................................................... 916 Gases, carbon monoxide in (2.5.25.)...................................... 175
Foams, intrauterine .................................................................. 914 Gases, nitrogen monoxide and nitrogen dioxide in
Foams, medicated ..................................................................... 911 (2.5.26.) .................................................................................... 176
Foams, rectal ............................................................................. 935 Gases, nitrous oxide in (2.5.35.) ............................................. 182
Foams, vaginal........................................................................... 941 Gases, oxygen in (2.5.27.) ........................................................ 176
Folic acid hydrate.................................................................... 2690
Gases, water in (2.5.28.)........................................................... 176 Granisetron hydrochloride.................................................... 2787

Gas-gangrene antitoxin, mixed ............................................. 1170 Granules..................................................................................... 912
Gas-gangrene antitoxin (novyi) ............................................ 1171 Granules and powders for oral solutions and suspensions.. 917
Gas-gangrene antitoxin (perfringens).................................. 1171 Granules and powders for syrups ........................................... 918
Gas-gangrene antitoxin (septicum)...................................... 1172 Granules and spheroids, friability of (2.9.41.)....................... 400
Gastrodia rhizome .................................................................. 1447 Granules, coated ....................................................................... 912
Gastro-resistant capsules ......................................................... 907 Granules, effervescent .............................................................. 912
Gastro-resistant granules ......................................................... 913 Granules, gastro-resistant ........................................................ 913
Gastro-resistant tablets ............................................................ 938 Granules, modified-release...................................................... 912
Gefitinib ................................................................................... 2737 Greater celandine.................................................................... 1463
Gelatin...................................................................................... 2738 Green tea.................................................................................. 1464
Gels............................................................................................. 936 Griseofulvin............................................................................. 2788
Gels for injections..................................................................... 925 Guaiacol ................................................................................... 2789
Gemcitabine hydrochloride................................................... 2739 Guaifenesin.............................................................................. 2791
Gemfibrozil.............................................................................. 2740 Guanethidine monosulfate .................................................... 2792
Gene transfer medicinal products for human use (5.14.).... 779 Guar.......................................................................................... 1466
General notices (1.) ...................................................................... 3 Guar galactomannan .............................................................. 2793
General texts on biological products (5.2.) ........................... 647 Guarana.................................................................................... 1467
General texts on microbiology (5.1.) ..................................... 619 Guidelines for using the test for bacterial endotoxins
Genetically modified cells........................................................ 779 (5.1.10.) .................................................................................... 639
Gentamicin sulfate.................................................................. 2742 Guidelines for using the test for sterility (5.1.9.) .................. 639
Gentian root ............................................................................ 1448
Gentian tincture...................................................................... 1449 H
Gestodene ................................................................................ 2744 Haemagglutinins, anti-A and anti-B (2.6.20.)....................... 218
Ginger ...................................................................................... 1450 Haematopoietic products, numeration of CD34/CD45+ cells
Gingival solutions ..................................................................... 921 in (2.7.23.) ............................................................................... 292
Ginkgo dry extract, refined and quantified......................... 1451 Haematopoietic progenitor cells, human, colony-forming cell
Ginkgo leaf .............................................................................. 1454 assay for (2.7.28.) .................................................................... 296
Ginseng .................................................................................... 1455 Haematopoietic stem cells, human....................................... 2857
Ginseng dry extract ................................................................ 1457 Haemodiafiltration and haemofiltration, concentrated
Glass containers for pharmaceutical use (3.2.1.) .................. 453 solutions for........................................................................... 2801
Glibenclamide ......................................................................... 2746 Haemodiafiltration and haemofiltration, solutions for...... 2803
Gliclazide ................................................................................. 2747 Haemodialysis, concentrated solutions for ......................... 2798
Glimepiride ............................................................................. 2749 Haemodialysis solutions, concentrated, water for
Glipizide................................................................................... 2751 diluting................................................................................... 2797
Glossary (dosage forms) .......................................................... 905 Haemodialysis, solutions for ................................................. 2798
Glucagon, human ................................................................... 2753 Haemofiltration and haemodiafiltration, concentrated
Glucoheptonate, calcium ....................................................... 2051 solutions for........................................................................... 2801
Glucosamine hydrochloride .................................................. 2754 Haemofiltration and haemodiafiltration, solutions for...... 2803
Glucosamine sulfate potassium chloride ............................. 2755 Haemophilus type b and meningococcal group C conjugate
Glucosamine sulfate sodium chloride.................................. 2757 vaccine ..................................................................................... 979
Glucose..................................................................................... 2758 Haemophilus type b (conjugate), diphtheria, tetanus and
Glucose, liquid ........................................................................ 2759 pertussis (acellular, component) vaccine (adsorbed)......... 961
Glucose, liquid, spray-dried .................................................. 2760 Haemophilus type b (conjugate), diphtheria, tetanus, pertussis
Glucose monohydrate ............................................................ 2761 (acellular, component) and poliomyelitis (inactivated)
Glutamic acid .......................................................................... 2762 vaccine (adsorbed) ................................................................. 970
Glutathione.............................................................................. 2763 Haemophilus type b (conjugate), diphtheria, tetanus, pertussis
Glycan analysis of glycoproteins (2.2.59.) ............................. 109 (acellular, component), hepatitis B (rDNA) and poliomyelitis
Glycerol.................................................................................... 2765 (inactivated) vaccine (adsorbed) .......................................... 968
Glycerol (85 per cent) ............................................................ 2766 Haemophilus type b (conjugate), diphtheria, tetanus,
Glycerol dibehenate................................................................ 2767 pertussis (whole cell) and poliomyelitis (inactivated) vaccine
Glycerol distearate .................................................................. 2768 (adsorbed) ............................................................................... 974
Glycerol formal ....................................................................... 2769 Haemophilus type b conjugate vaccine.................................. 980
Glycerol monocaprylate......................................................... 2770 Haemorrhagic disease vaccine (inactivated), rabbit........... 1147
Glycerol monocaprylocaprate ............................................... 2771 Halofantrine hydrochloride................................................... 2805
Glycerol monolinoleate.......................................................... 2772 Haloperidol.............................................................................. 2806
Glycerol mono-oleate ............................................................. 2773 Haloperidol decanoate ........................................................... 2808
Glycerol monostearate 40-55 ................................................ 2774 Halothane ................................................................................ 2809
Glycerol triacetate................................................................... 4083 Hamamelis bark ...................................................................... 1468
Glyceryl trinitrate solution .................................................... 2775 Hamamelis leaf........................................................................ 1469
Glycine ..................................................................................... 2777 Hard capsules ............................................................................ 906
Glycoproteins, glycan analysis of (2.2.59.) ............................ 109 Hard fat .................................................................................... 2811
Glycopyrronium bromide...................................................... 2779 Hard fat with additives........................................................... 2812
Glycyrrhizate ammonium...................................................... 1833 Hard paraffin........................................................................... 3483
Goldenrod................................................................................ 1458 Harmonisation, pharmacopoeial (5.8.).................................. 755
Goldenrod, European............................................................. 1460 Hawthorn berries.................................................................... 1470
Goldenseal rhizome................................................................ 1461 Hawthorn leaf and flower ...................................................... 1471
Gonadorelin acetate................................................................ 2781 Hawthorn leaf and flower dry extract .................................. 1472
Gonadotrophin, chorionic..................................................... 2782 Hawthorn leaf and flower liquid extract, quantified .......... 1473
Gonadotrophin, equine serum, for veterinary use............. 2783 HCP assays (2.6.34.) ................................................................. 244
Goserelin.................................................................................. 2783 Healthy chicken flocks for the production of inactivated
Grafted copolymer, macrogol poly(vinyl alcohol) ............. 3140 vaccines for veterinary use (5.2.13.)..................................... 679
Gramicidin .............................................................................. 2785

Heavy bismuth subnitrate...................................................... 1985 Histamine (2.6.10.) ................................................................... 200

Heavy kaolin............................................................................ 3031 Histamine dihydrochloride ................................................... 2825
Heavy magnesium carbonate ................................................ 3153 Histaminum for homoeopathic preparations ..................... 1716
Heavy magnesium oxide........................................................ 3159 Histidine .................................................................................. 2826
Heavy metals (2.4.8.)................................................................ 139 Histidine hydrochloride monohydrate ................................ 2827
Heavy metals in herbal drugs and herbal drug preparations Homatropine hydrobromide ................................................. 2829
(2.4.27.) .................................................................................... 158 Homatropine methylbromide ............................................... 2830
Hedera helix for homoeopathic preparations ..................... 1715 Homoeopathic pillules, coated.............................................. 1697
Helium ..................................................................................... 2814 Homoeopathic pillules, impregnated ................................... 1697
Heparin, assay of (2.7.5.) ......................................................... 269 Homoeopathic preparations.................................................. 1679
Heparin calcium ..................................................................... 2814 Homoeopathic preparations, acidum picrinicum for ........ 1698
Heparin in coagulation factors, assay of (2.7.12.)................. 281 Homoeopathic preparations, acidum succinicum for........ 1698
Heparin sodium ...................................................................... 2816 Homoeopathic preparations, Agaricus phalloides for ....... 1699
Heparins, low-molecular-mass ............................................. 2818 Homoeopathic preparations, Allium sativum for .............. 1701
Hepatitis A immunoglobulin, human.................................. 2858 Homoeopathic preparations, ammonium carbonicum
Hepatitis A (inactivated, adsorbed) and typhoid polysaccharide for ........................................................................................... 1701
vaccine ..................................................................................... 982 Homoeopathic preparations, Anacardium for.................... 1702
Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine Homoeopathic preparations, Apis for.................................. 1703
(adsorbed) ............................................................................... 983 Homoeopathic preparations, arsenicum album for ........... 1704
Hepatitis A vaccine, assay of (2.7.14.).................................... 284 Homoeopathic preparations, aurum chloratum natronatum
Hepatitis A vaccine (inactivated, adsorbed).......................... 984 for .......................................................................................... 1704
Hepatitis A vaccine (inactivated, virosome) ......................... 985 Homoeopathic preparations, barium chloratum for.......... 1705
Hepatitis B immunoglobulin for intravenous administration, Homoeopathic preparations, Belladonna for...................... 1705
human .................................................................................... 2859 Homoeopathic preparations, cadmium sulfuricum for..... 1707
Hepatitis B immunoglobulin, human .................................. 2858 Homoeopathic preparations, calcium fluoratum for ......... 1707
Hepatitis B (rDNA), diphtheria and tetanus vaccine Homoeopathic preparations, calcium iodatum for ............ 1708
(adsorbed) ............................................................................... 954 Homoeopathic preparations, Cocculus for ......................... 1708
Hepatitis B (rDNA), diphtheria, tetanus and pertussis Homoeopathic preparations, Crocus for ............................. 1710
(acellular, component) vaccine (adsorbed)......................... 963 Homoeopathic preparations, cuprum aceticum for........... 1711
Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular, Homoeopathic preparations, cuprum metallicum for....... 1712
component), poliomyelitis (inactivated) and haemophilus Homoeopathic preparations, digitalis for ........................... 1712
type b conjugate vaccine (adsorbed).................................... 968 Homoeopathic preparations, ferrum metallicum for ........ 1714
Hepatitis B vaccine (rDNA) .................................................... 988 Homoeopathic preparations, hedera helix for .................... 1715
Hepatitis B vaccine (rDNA), assay of (2.7.15.)...................... 285 Homoeopathic preparations, herbal drugs for.................... 1680
Hepatitis C virus (HCV), validation of nucleic acid Homoeopathic preparations, histaminum for .................... 1716
amplification techniques for the detection of HCV RNA in Homoeopathic preparations, hydrastis canadensis for ...... 1716
plasma pools : guidelines ....................................................... 219 Homoeopathic preparations, hyoscyamus for .................... 1717
Hepatitis type I vaccine (live), viral, duck ........................... 1099 Homoeopathic preparations, hypericum for....................... 1718
Heptaminol hydrochloride .................................................... 2821 Homoeopathic preparations : introduction ......................... 1679
Herbal drug extracts................................................................. 865 Homoeopathic preparations, kalium bichromicum for..... 1721
Herbal drug extracts, monographs on (information chapter) Homoeopathic preparations, magnesium fluoratum for... 1722
(5.23.) ....................................................................................... 843 Homoeopathic preparations, magnesium phosphoricum
Herbal drug preparations ........................................................ 869 for ........................................................................................... 1722
Herbal drugs.............................................................................. 869 Homoeopathic preparations, mother tinctures for ............ 1681
Herbal drugs and herbal drug preparations, heavy metals in Homoeopathic preparations, Nux-vomica for .................... 1723
(2.4.27.) .................................................................................... 158 Homoeopathic preparations, petroleum rectificatum for.. 1725
Herbal drugs and herbal drug preparations, high-performance Homoeopathic preparations, pillules for ............................. 1696
thin-layer chromatography of (2.8.25.)................................ 318 Homoeopathic preparations, selenium for.......................... 1725
Herbal drugs, determination of aflatoxin B1 in (2.8.18.) ..... 311 Homoeopathic preparations, Staphysagria for.................... 1726
Herbal drugs, essential oils in (2.8.12.).................................. 307 Homoeopathic preparations, sulfur for ............................... 1727
Herbal drugs for homoeopathic preparations..................... 1680 Homoeopathic preparations, Urtica dioica for ................... 1728
Herbal drugs : introduction ................................................... 1289 Homoeopathic stocks (methods of preparation of) and
Herbal drugs, microscopic examination of (2.8.23)............. 317 potentisation ......................................................................... 1682
Herbal drugs : sampling and sample preparation (2.8.20.).. 313 Homoepathic preparations, Ignatia for................................ 1719
Herbal drugs, tannins in (2.8.14.)........................................... 310 Honey ....................................................................................... 2831
Herbal drugs, test for aristolochic acids in (2.8.21) ............. 314 Honey bee for homoeopathic preparations......................... 1703
Herbal medicinal products for oral use and extracts used in Hop strobile............................................................................. 1474
their preparation, microbiological examination (2.6.31.).. 239 Horse-chestnut........................................................................ 1475
Herbal medicinal products for oral use and extracts used in Horse-chestnut dry extract, standardised............................ 1477
their preparation, microbiological quality (5.1.8.) ............. 638 Host-cell DNA, residual, quantification and characterisation
Herbal preparations.................................................................. 869 of (2.6.35.)................................................................................ 248
Herbal substances ..................................................................... 869 Host-cell protein assays (2.6.34.) ............................................ 244
Herbal teas................................................................................. 870 Houttuynia herb...................................................................... 1478
Herbal teas, instant................................................................... 871 Human α-1-proteinase inhibitor .......................................... 2869
Herpes zoster (shingles) vaccine (live)................................. 1036 Human α-1-proteinase inhibitor, assay of (2.7.32.).............. 300
Herpesvirus vaccine (inactivated), equine........................... 1103 Human albumin injection, iodinated (125I) ......................... 1210
Hexamidine diisetionate ........................................................ 2822 Human albumin solution ...................................................... 2832
Hexetidine ............................................................................... 2823 Human anti-D immunoglobulin .......................................... 2834
Hexosamines in polysaccharide vaccines (2.5.20.) ............... 173 Human anti-D immunoglobulin, assay of (2.7.13.) ............. 282
Hexylresorcinol ....................................................................... 2824 Human anti-D immunoglobulin for intravenous
High-molecular-mass macrogols.......................................... 3147 administration....................................................................... 2835
High-performance thin-layer chromatography of herbal drugs Human antithrombin III, assay of (2.7.17.)........................... 288
and herbal drug preparations (2.8.25.) ................................ 318 Human antithrombin III concentrate .................................. 2835
Human C1-esterase inhibitor................................................ 2837 Hydrous wool fat .................................................................... 4216

Human C1-esterase inhibitor, assay of (2.7.34.) ................... 301 Hydroxocobalamin acetate .................................................... 2892
Human coagulation factor II, assay of (2.7.18.).................... 288 Hydroxocobalamin chloride.................................................. 2893
Human coagulation factor IX ............................................... 2846 Hydroxocobalamin sulfate..................................................... 2894
Human coagulation factor IX, assay of (2.7.11.) .................. 281 Hydroxycarbamide ................................................................. 2895
Human coagulation factor IX (rDNA) concentrated Hydroxychloroquine sulfate .................................................. 2896
solution .................................................................................. 2848 Hydroxyethyl salicylate .......................................................... 2897
Human coagulation factor IX (rDNA) powder for solution for Hydroxyethyl starches ............................................................ 3892
injection ................................................................................. 2853 Hydroxyethylcellulose ............................................................ 2898
Human coagulation factor VII.............................................. 2838 Hydroxyethylmethylcellulose ................................................ 3237
Human coagulation factor VII, assay of (2.7.10.)................. 280 Hydroxyl value (2.5.3.)............................................................. 167
Human coagulation factor VIIa (rDNA) concentrated Hydroxypropyl starch............................................................. 3888
solution .................................................................................. 2840 Hydroxypropyl starch, pregelatinised .................................. 3890
Human coagulation factor VIII ............................................ 2844 Hydroxypropylbetadex........................................................... 2901
Human coagulation factor VIII, assay of (2.7.4.) ................. 268 Hydroxypropylcellulose ......................................................... 2903
Human coagulation factor VIII (rDNA) ............................. 2845 Hydroxypropylcellulose, low-substituted ............................ 2904
Human coagulation factor X, assay of (2.7.19.) .................... 289 Hydroxypropylmethylcellulose ............................................. 2914
Human coagulation factor XI ............................................... 2855 Hydroxypropylmethylcellulose phthalate ............................ 2916
Human coagulation factor XI, assay of (2.7.22.) .................. 291 Hydroxyzine hydrochloride................................................... 2906
Human fibrinogen .................................................................. 2856 Hymecromone......................................................................... 2907
Human glucagon..................................................................... 2753 Hymenoptera venoms for allergen products....................... 2908
Human haematopoietic progenitor cells, colony-forming cell Hyoscine .................................................................................. 2909
assay for (2.7.28.) .................................................................... 296 Hyoscine butylbromide.......................................................... 2910
Human haematopoietic stem cells........................................ 2857 Hyoscine hydrobromide ........................................................ 2911
Human hepatitis A immunoglobulin................................... 2858 Hyoscyamine sulfate............................................................... 2913
Human hepatitis B immunoglobulin ................................... 2858 Hyoscyamus for homoeopathic preparations ..................... 1717
Human hepatitis B immunoglobulin for intravenous Hypericum............................................................................... 1631
administration....................................................................... 2859 Hypericum for homoeopathic preparations........................ 1718
Human insulin ........................................................................ 2951 Hypromellose .......................................................................... 2914
Human measles immunoglobulin ........................................ 2859 Hypromellose phthalate ......................................................... 2916
Human normal immunoglobulin for intramuscular
administration....................................................................... 2860 I
Human normal immunoglobulin for intravenous Ibuprofen ................................................................................. 2921
administration....................................................................... 2862 Iceland moss............................................................................ 1480
Human normal immunoglobulin for subcutaneous ICH (5.8.)................................................................................... 755
administration....................................................................... 2864 Ichthammol ............................................................................. 2923
Human papillomavirus vaccine (rDNA) ............................... 989 Identification (2.3.) ................................................................... 129
Human plasma for fractionation .......................................... 2865 Identification and control of residual solvents (2.4.24.) ...... 152
Human plasma (pooled and treated for virus Identification of fatty oils by thin-layer chromatography
inactivation) .......................................................................... 2867 (2.3.2.) ...................................................................................... 132
Human plasmin inhibitor, assay of (2.7.25.) ......................... 295 Identification of phenothiazines by thin-layer chromatography
Human protein C, assay of (2.7.30.)....................................... 299 (2.3.3.) ...................................................................................... 133
Human protein S, assay of (2.7.31.)........................................ 300 Identification reactions of ions and functional groups
Human prothrombin complex .............................................. 2870 (2.3.1.) ...................................................................................... 129
Human rabies immunoglobulin ........................................... 2871 Idoxuridine .............................................................................. 2924
Human rubella immunoglobulin ......................................... 2872 Ifosfamide ................................................................................ 2925
Human tetanus immunoglobulin ......................................... 2873 Ignatia for homoeopathic preparations ............................... 1719
Human varicella immunoglobulin ....................................... 2875 Imatinib mesilate .................................................................... 2926
Human varicella immunoglobulin for intravenous Imidacloprid for veterinary use ............................................ 2929
administration....................................................................... 2875 Imipenem monohydrate ........................................................ 2930
Human von Willebrand factor .............................................. 2875 Imipramine hydrochloride .................................................... 2931
Human von Willebrand factor, assay of (2.7.21.) ................. 290 Immunochemical methods (2.7.1.) ........................................ 261
Hyaluronate, sodium.............................................................. 3821 Immunoglobulin for human use, anti-T lymphocyte,
Hyaluronidase ........................................................................ 2877 animal .................................................................................... 1858
Hydralazine hydrochloride.................................................... 2878 Immunoglobulin for intramuscular administration, human
Hydrastis canadensis for homoeopathic preparations ....... 1716 normal.................................................................................... 2860
Hydrochloric acid, concentrated .......................................... 2879 Immunoglobulin for intravenous administration, human
Hydrochloric acid, dilute ....................................................... 2879 anti-D ..................................................................................... 2835
Hydrochlorothiazide .............................................................. 2879 Immunoglobulin for intravenous administration, human
Hydrocodone hydrogen tartrate 2.5-hydrate ...................... 2881 hepatitis B.............................................................................. 2859
Hydrocortisone ....................................................................... 2883 Immunoglobulin for intravenous administration, human
Hydrocortisone acetate .......................................................... 2886 normal.................................................................................... 2862
Hydrocortisone hydrogen succinate..................................... 2888 Immunoglobulin for intravenous administration, human
Hydrogen peroxide solution (3 per cent) ............................ 2889 varicella.................................................................................. 2875
Hydrogen peroxide solution (30 per cent) .......................... 2890 Immunoglobulin for subcutaneous administration, human
Hydrogenated arachis oil ....................................................... 1869 normal.................................................................................... 2864
Hydrogenated castor oil......................................................... 2102 Immunoglobulin, human anti-D .......................................... 2834
Hydrogenated cottonseed oil................................................. 2317 Immunoglobulin, human anti-D, assay of (2.7.13.) ............. 282
Hydrogenated soya-bean oil.................................................. 3872 Immunoglobulin, human hepatitis A .................................. 2858
Hydrogenated vegetable oils, nickel in (2.4.31.) ................... 163 Immunoglobulin, human hepatitis B................................... 2858
Hydrogenated wool fat........................................................... 4215 Immunoglobulin, human measles ........................................ 2859
Hydromorphone hydrochloride............................................ 2890 Immunoglobulin, human rabies ........................................... 2871
Hydrophobic colloidal silica.................................................. 3789

Immunoglobulin, human rubella ......................................... 2872 Inhalation, preparations for .................................................... 927
Immunoglobulin, human tetanus......................................... 2873 Inhalation, preparations for : aerodynamic assessment of fine
Immunoglobulin, human varicella....................................... 2875 particles (2.9.18.) .................................................................... 347
Immunoglobulin, test for anticomplementary activity of Injectable insulin preparations.............................................. 2959
(2.6.17.) .................................................................................... 216 Injections ................................................................................... 923
Immunoglobulin, test for Fc function of (2.7.9.).................. 279 Injections, gels for..................................................................... 925
Immunological veterinary medicinal products, substances of Injections or infusions, concentrates for ............................... 924
animal origin for the production of (5.2.5.)........................ 656 Injections or infusions, powders for....................................... 924
Immunonephelometry for vaccine component assay Inositol, myo- .......................................................................... 2944
(2.7.35.) .................................................................................... 301 Inserts, ophthalmic................................................................... 910
Immunosera and vaccines, phenol in (2.5.15.) ..................... 172 Instant herbal teas .................................................................... 871
Immunosera and vaccines, veterinary, evaluation of efficacy Insulin aspart........................................................................... 2945
of (5.2.7.).................................................................................. 661 Insulin, bovine ........................................................................ 2946
Immunosera and vaccines, veterinary, evaluation of safety Insulin glargine ....................................................................... 2949
(5.2.6.) ...................................................................................... 658 Insulin, human........................................................................ 2951
Immunosera for human use, animal ...................................... 871 Insulin injection, biphasic ..................................................... 2953
Immunosera for veterinary use............................................... 873 Insulin injection, biphasic isophane..................................... 2953
Immunosera for veterinary use, evaluation of the safety of Insulin injection, isophane .................................................... 2954
each batch (5.2.9.)................................................................... 673 Insulin injection, soluble ....................................................... 2954
Implants ..................................................................................... 925 Insulin lispro ........................................................................... 2954
Impurities, elemental, determination of (2.4.20.)................. 144 Insulin, porcine ....................................................................... 2957
Impurities in substances for pharmaceutical use, control of Insulin preparations, injectable............................................. 2959
(5.10.) ....................................................................................... 763 Insulin zinc injectable suspension ........................................ 2961
In vitro method(s) for the quality control of vaccines, Insulin zinc injectable suspension (amorphous) ................ 2962
substitution of in vivo method(s) by (5.2.14.)..................... 679 Insulin zinc injectable suspension (crystalline) .................. 2962
In vivo assay of poliomyelitis vaccine (inactivated) Interferon alfa-2 concentrated solution ............................... 2963
(2.7.20.) .................................................................................... 289 Interferon beta-1a concentrated solution ............................ 2965
Inactivated vaccines for veterinary use, healthy chicken flocks Interferon gamma-1b concentrated solution ...................... 2968
for the production of (5.2.13.) .............................................. 679 Interferons, assay of (5.6.)........................................................ 741
Indapamide.............................................................................. 2932 International System (SI) units (1.) ............................................ 3
Index, foam (2.8.24.) ................................................................ 317 Intramammary preparations for veterinary use ................... 913
Indian frankincense................................................................ 1480 Intraruminal delivery systems ................................................ 913
Indicators, approximate pH of solutions (2.2.4.) .................... 25 Intrauterine capsules ................................................................ 914
Indigo plant leaf ...................................................................... 1481 Intrauterine foams .................................................................... 914
Indinavir sulfate ...................................................................... 2934 Intrauterine preparations for veterinary use ......................... 914
Indium (111In) chloride solution ........................................... 1211 Intrauterine solutions, suspensions ........................................ 914
Indium (111In) oxine solution ................................................ 1212 Intrauterine sticks..................................................................... 914
Indium (111In) pentetate injection ........................................ 1213 Intrauterine tablets ................................................................... 914
Indometacin ............................................................................ 2936 Intrinsic dissolution (2.9.29.) .................................................. 372
Inductively coupled plasma-atomic emission spectrometry Iobenguane (123I) injection .................................................... 1213
(2.2.57.) .................................................................................... 106 Iobenguane (131I) injection for diagnostic use..................... 1214
Inductively coupled plasma-mass spectrometry (2.2.58.) ... 108 Iobenguane (131I) injection for therapeutic use................... 1215
Infectious bovine rhinotracheitis vaccine (inactivated)..... 1120 Iobenguane sulfate for radiopharmaceutical prepara-
Infectious bovine rhinotracheitis vaccine (live).................. 1121 tions........................................................................................ 1216
Infectious bronchitis vaccine (inactivated), avian .............. 1059 Iodinated (125I) human albumin injection ........................... 1210
Infectious bronchitis vaccine (live), avian ........................... 1060 Iodinated povidone ................................................................ 3615
Infectious bursal disease vaccine (inactivated), avian........ 1062 Iodine ....................................................................................... 2971
Infectious bursal disease vaccine (live), avian..................... 1063 Iodine value (2.5.4.).................................................................. 167
Infectious chicken anaemia vaccine (live) ........................... 1122 Iodixanol.................................................................................. 2971
Infectious encephalomyelitis vaccine (live), avian.............. 1065 Iodohippurate (sodium) dihydrate for radiopharmaceutical
Infectious enteritis vaccine (inactivated), feline ................. 1109 preparations .......................................................................... 1234
Infectious enteritis vaccine (live), feline .............................. 1110 Iodomethylnorcholesterol (131I) injection............................ 1217
Infectious laryngotracheitis vaccine (live), avian ............... 1066 Iohexol...................................................................................... 2974
Infectious pancreatic necrosis vaccine (inactivated, Ionic concentration, potentiometric determination of using
oil-adjuvanted, injectable) for salmonids .......................... 1124 ion-selective electrodes (2.2.36.)............................................. 64
Infectious rhinotracheitis vaccine (live), turkey ................. 1162 Ions and functional groups, identification reactions of
Infliximab concentrated solution.......................................... 2938 (2.3.1.) ...................................................................................... 129
Influenza vaccine (inactivated), equine ............................... 1104 Ion-selective electrodes, potentiometric determination of
Influenza vaccine (inactivated), porcine.............................. 1142 ionic concentration (2.2.36.) ................................................... 64
Influenza vaccine (live, nasal) ................................................. 992 Iopamidol................................................................................. 2978
Influenza vaccine (split virion, inactivated) .......................... 995 Iopanoic acid ........................................................................... 2980
Influenza vaccine (surface antigen, inactivated)................... 996 Iopromide ................................................................................ 2981
Influenza vaccine (surface antigen, inactivated, prepared in Iotrolan .................................................................................... 2984
cell cultures) ............................................................................ 998 Ioxaglic acid............................................................................. 2986
Influenza vaccine (surface antigen, inactivated, Ipecacuanha liquid extract, standardised ............................ 1483
virosome)............................................................................... 1000 Ipecacuanha, prepared ........................................................... 1483
Influenza vaccine (whole virion, inactivated) ..................... 1002 Ipecacuanha root .................................................................... 1485
Influenza vaccine (whole virion, inactivated, prepared in cell Ipecacuanha tincture, standardised...................................... 1486
cultures) ................................................................................. 1003 Ipratropium bromide ............................................................. 2988
Infrared absorption spectrophotometry (2.2.24.)................... 39 Irbesartan................................................................................. 2990
Infusions .................................................................................... 924 Irinotecan hydrochloride trihydrate..................................... 2991
Inhalation gas, krypton (81mKr)............................................. 1217 Iron (2.4.9.)................................................................................ 142
Inhalation powders................................................................... 931 Iron for homoeopathic preparations.................................... 1714
Irrigation, preparations for...................................................... 932 Laryngotracheitis vaccine (live), infectious, avian ............. 1066
Isatis root ................................................................................. 1487 Laser light diffraction, particle size analysis by (2.9.31.) .... 373
Isoconazole .............................................................................. 2993 Laurilsulfate, sodium.............................................................. 3827
Isoconazole nitrate.................................................................. 2994 Lauromacrogol 400................................................................. 3065
Isoelectric focusing (2.2.54.) ..................................................... 95 Lauroyl macrogolglycerides................................................... 3068
Isoflurane ................................................................................. 2996 Lavender flower ...................................................................... 1497
Isoleucine................................................................................. 2997 Lavender oil............................................................................. 1499
Isomalt ..................................................................................... 2998 Lavender oil, spike.................................................................. 1630
Isoniazid................................................................................... 3000 Lead in sugars (2.4.10.) ............................................................ 142
Isophane insulin injection ..................................................... 2954 Leflunomide ............................................................................ 3069
Isoprenaline hydrochloride ................................................... 3001 Lemon oil................................................................................. 1500
Isoprenaline sulfate................................................................. 3002 Lemon verbena leaf ................................................................ 1502
Isopropyl alcohol .................................................................... 3003 Leptospirosis vaccine (inactivated), bovine......................... 1071
Isopropyl isostearate............................................................... 3004 Leptospirosis vaccine (inactivated), canine ......................... 1082
Isopropyl myristate................................................................. 3004 Letrozole .................................................................................. 3070
Isopropyl palmitate................................................................. 3005 Leucine..................................................................................... 3071
Isosorbide dinitrate, diluted ................................................. 3006 Leukaemia vaccine (inactivated), feline............................... 1112
Isosorbide mononitrate, diluted .......................................... 3007 Leuprorelin .............................................................................. 3073
Isotherms (sorption-desorption) and water activity, Levamisole for veterinary use ............................................... 3074
determination of (water-solid interactions) (2.9.39.)......... 394 Levamisole hydrochloride ..................................................... 3075
Isotretinoin .............................................................................. 3009 Levetiracetam .......................................................................... 3077
Isoxsuprine hydrochloride..................................................... 3010 Levocabastine hydrochloride ................................................ 3078
Ispaghula husk ........................................................................ 1488 Levocarnitine........................................................................... 3080
Ispaghula seed ......................................................................... 1489 Levodopa ................................................................................. 3082
Isradipine ................................................................................. 3012 Levodropropizine.................................................................... 3083
Itraconazole ............................................................................. 3013 Levofloxacin hemihydrate ..................................................... 3085
Ivermectin................................................................................ 3015 Levofolinate hydrate, calcium ............................................... 2060
Ivy leaf ...................................................................................... 1489 Levomenthol............................................................................ 3086
Levomepromazine hydrochloride......................................... 3087
J Levomepromazine maleate.................................................... 3088
Java tea ..................................................................................... 1491 Levomethadone hydrochloride ............................................. 3089
Javanese turmeric.................................................................... 1652 Levonorgestrel......................................................................... 3091
Josamycin................................................................................. 3021 Levothyroxine sodium ........................................................... 3094
Josamycin propionate............................................................. 3023 Levulinate dihydrate, calcium ............................................... 2062
Juniper...................................................................................... 1492 Lidocaine ................................................................................. 3095
Juniper oil ................................................................................ 1493 Lidocaine hydrochloride monohydrate ............................... 3097
Light liquid paraffin ............................................................... 3483
Light magnesium carbonate .................................................. 3153
K
Light magnesium oxide.......................................................... 3160
Kalium bichromicum for homoeopathic preparations...... 1721 Lightyellow sophora root....................................................... 1503
Kanamycin acid sulfate .......................................................... 3029 Ligusticum root and rhizome ............................................... 1505
Kanamycin monosulfate ........................................................ 3030 Lime flower.............................................................................. 1506
Kaolin, heavy........................................................................... 3031 Limit tests (2.4.) ........................................................................ 137
Kelp........................................................................................... 1494 Limit tests, standard solutions for (4.1.2.)............................. 598
Ketamine hydrochloride ........................................................ 3031 Lincomycin hydrochloride .................................................... 3098
Ketobemidone hydrochloride ............................................... 3032 Linen thread, sterile, in distributor for veterinary use ..... 1282
Ketoconazole ........................................................................... 3033 Linoleoyl macrogolglycerides................................................ 3100
Ketoprofen ............................................................................... 3035 Linseed ..................................................................................... 1507
Ketorolac trometamol ............................................................ 3037 Linseed oil, virgin ................................................................... 3101
Ketotifen hydrogen fumarate ................................................ 3038 Liothyronine sodium.............................................................. 3101
Knotgrass ................................................................................. 1495 Lipophilic solid dosage forms, dissolution test for
Krypton (81mKr) inhalation gas ............................................. 1217 (2.9.42.) .................................................................................... 401
Kudzuvine root ....................................................................... 1496 Liquid chromatography (2.2.29.) .............................................. 49
Kudzuvine root, Thomson..................................................... 1644 Liquid extraction preparations ............................................... 867
Liquid (fluid) extracts .............................................................. 867
L Liquid glucose ......................................................................... 2759
Labetalol hydrochloride......................................................... 3043 Liquid glucose, spray-dried ................................................... 2760
Lacosamide.............................................................................. 3045 Liquid lactulose....................................................................... 3058
Lacosamide infusion .............................................................. 3046 Liquid maltitol ........................................................................ 3171
Lacosamide oral solution....................................................... 3047 Liquid paraffin ........................................................................ 3484
Lacosamide tablets.................................................................. 3049 Liquid paraffin, light .............................................................. 3483
Lactic acid................................................................................ 3050 Liquid preparations for cutaneous application ..................... 916
Lactic acid, (S)- ....................................................................... 3051 Liquid preparations for cutaneous application, veterinary.. 941
Lactitol monohydrate ............................................................. 3051 Liquid preparations for oral use ............................................. 916
Lactobionic acid...................................................................... 3053 Liquid sorbitol (crystallising)................................................ 3867
Lactose ..................................................................................... 3054 Liquid sorbitol (non-crystallising) ....................................... 3867
Lactose monohydrate ............................................................. 3055 Liquid sorbitol, partially dehydrated.................................... 3868
Lactulose .................................................................................. 3056 Liquid sucrose ......................................................................... 3908
Lactulose, liquid...................................................................... 3058 Liquids, clarity and degree of opalescence of (2.2.1.) ............ 21
Lamivudine.............................................................................. 3060 Liquorice dry extract for flavouring purposes .................... 1508
Lamotrigine ............................................................................. 3063 Liquorice root ......................................................................... 1509
Lansoprazole ........................................................................... 3064 Lisinopril dihydrate ................................................................ 3103
Largehead atractylodes rhizome ........................................... 1328 Lithium carbonate .................................................................. 3104

Lithium citrate ........................................................................ 3105 Magnesium glycerophosphate............................................... 3158

Live biotherapeutic products for human use ........................ 876 Magnesium hydroxide............................................................ 3158
Live biotherapeutic products, microbiological examination Magnesium lactate dihydrate ................................................ 3159
of (tests for enumeration of microbial contaminants) Magnesium oxide, heavy ....................................................... 3159
(2.6.36.) .................................................................................... 250 Magnesium oxide, light.......................................................... 3160
Live biotherapeutic products, microbiological examination of Magnesium peroxide.............................................................. 3161
(tests for specified micro-organisms) (2.6.38.) ................... 255 Magnesium phosphoricum for homoeopathic
L-Methionine ([11C]methyl) injection .................................. 1220 preparations .......................................................................... 1722
Lobeline hydrochloride.......................................................... 3105 Magnesium pidolate ............................................................... 3161
Lomustine ................................................................................ 3107 Magnesium stearate................................................................ 3163
Long pepper ............................................................................ 1510 Magnesium sulfate heptahydrate .......................................... 3165
Loosestrife ............................................................................... 1511 Magnesium trisilicate ............................................................. 3165
Loperamide hydrochloride.................................................... 3108 Magnolia biondii flower bud................................................. 1515
Loperamide oxide monohydrate........................................... 3109 Magnolia officinalis bark ....................................................... 1517
Lopinavir.................................................................................. 3111 Magnolia officinalis flower .................................................... 1519
Loratadine................................................................................ 3114 Maize oil, refined .................................................................... 3166
Lorazepam ............................................................................... 3116 Maize starch ............................................................................ 3167
Losartan potassium ................................................................ 3117 Malathion................................................................................. 3167
Loss on drying (2.2.32.) ............................................................. 57 Maleic acid............................................................................... 3168
Loss on drying of extracts (2.8.17.) ........................................ 311 Malic acid ................................................................................ 3169
Lovage root.............................................................................. 1512 Mallow flower.......................................................................... 1520
Lovastatin ................................................................................ 3120 Mallow leaf .............................................................................. 1521
Low-molecular-mass heparins.............................................. 2818 Maltitol..................................................................................... 3170
Low-substituted carmellose sodium..................................... 2094 Maltitol, liquid ........................................................................ 3171
Low-substituted hydroxypropylcellulose ............................. 2904 Maltodextrin............................................................................ 3172
Lozenges and pastilles .............................................................. 922 Mandarin epicarp and mesocarp.......................................... 1522
Lozenges, compressed .............................................................. 922 Mandarin oil............................................................................ 1524
Lubricant, silicone oil (3.1.8.).................................................. 436 Manganese gluconate ............................................................. 3173
Lufenuron for veterinary use ................................................ 3121 Manganese glycerophosphate, hydrated .............................. 3174
Lutetium (177Lu) solution for radiolabelling........................ 1218 Manganese sulfate monohydrate .......................................... 3174
Lycopus lucidus herb.............................................................. 1514 Mannheimia vaccine (inactivated) for cattle....................... 1125
Lymecycline............................................................................. 3123 Mannheimia vaccine (inactivated) for sheep ...................... 1126
Lynestrenol .............................................................................. 3125 Mannitol .................................................................................. 3175
Lyophilisates, oral ..................................................................... 939 Maprotiline hydrochloride .................................................... 3177
Lysine acetate .......................................................................... 3126 Marbofloxacin for veterinary use ......................................... 3178
Lysine hydrochloride.............................................................. 3127 Marek’s disease vaccine (live)................................................ 1128
Marshmallow leaf ................................................................... 1525
M Marshmallow root .................................................................. 1526
Macrogol 15 hydroxystearate ................................................ 3133 Mass spectrometry (2.2.43.) ...................................................... 77
Macrogol 20 glycerol monostearate...................................... 3134 Mass spectrometry, inductively coupled plasma- (2.2.58.).. 108
Macrogol 30 dipolyhydroxystearate ..................................... 3135 Mass uniformity of delivered doses from multidose containers
Macrogol 40 sorbitol heptaoleate.......................................... 3135 (2.9.27.) .................................................................................... 372
Macrogol 6 glycerol caprylocaprate...................................... 3133 Mass uniformity of single-dose preparations (2.9.5.) .......... 335
Macrogol cetostearyl ether .................................................... 3136 Mastic ....................................................................................... 1526
Macrogol isotridecyl ether..................................................... 3137 Mate leaf................................................................................... 1527
Macrogol lauryl ether............................................................. 3137 Materials based on non-plasticised poly(vinyl chloride)
Macrogol oleate....................................................................... 3139 for containers for non-injectable, aqueous solutions
Macrogol oleyl ether............................................................... 3140 (3.1.10.) .................................................................................... 437
Macrogol poly(vinyl alcohol) grafted copolymer ............... 3140 Materials based on non-plasticised poly(vinyl chloride) for
Macrogol stearate.................................................................... 3142 containers for solid dosage forms for oral administration
Macrogol stearyl ether ........................................................... 3142 (3.1.11.) .................................................................................... 439
Macrogolglycerol cocoates..................................................... 3143 Materials based on plasticised poly(vinyl chloride) for
Macrogolglycerol hydroxystearate ........................................ 3144 containers for aqueous solutions for intravenous infusion
Macrogolglycerol ricinoleate ................................................. 3144 (3.1.14.) .................................................................................... 445
Macrogols ................................................................................ 3145 Materials based on plasticised poly(vinyl chloride) for
Macrogols, high-molecular-mass ......................................... 3147 containers for human blood and blood components
Magaldrate............................................................................... 3148 (3.3.2.) ...................................................................................... 465
Magnesium (2.4.6.)................................................................... 138 Materials based on plasticised poly(vinyl chloride) for
Magnesium acetate tetrahydrate ........................................... 3149 tubing used in sets for the transfusion of blood and blood
Magnesium aluminium silicate............................................. 1799 components (3.3.3.)................................................................ 468
Magnesium aluminometasilicate .......................................... 3150 Materials for containers for human blood and blood
Magnesium and alkaline-earth metals (2.4.7.)...................... 139 components (3.3.1.)................................................................ 465
Magnesium aspartate dihydrate............................................ 3151 Materials used for the manufacture of containers (3.1.)...... 423
Magnesium carbonate, heavy................................................ 3153 Matricaria flower .................................................................... 1529
Magnesium carbonate, light .................................................. 3153 Matricaria liquid extract ........................................................ 1530
Magnesium chloride 4.5-hydrate.......................................... 3154 Matricaria oil........................................................................... 1531
Magnesium chloride hexahydrate ........................................ 3155 Meadowsweet .......................................................................... 1533
Magnesium citrate .................................................................. 3155 Measles immunoglobulin, human ........................................ 2859
Magnesium citrate dodecahydrate........................................ 3156 Measles, mumps and rubella vaccine (live)......................... 1005
Magnesium citrate nonahydrate ........................................... 3157 Measles, mumps, rubella and varicella vaccine (live) ........ 1006
Magnesium fluoratum for homoeopathic preparations..... 1722 Measles vaccine (live)............................................................. 1007
Magnesium gluconate ............................................................ 3157 Measurement and detection of radioactivity (2.2.66.) ......... 119
Measurement of consistency by penetrometry (2.9.9.)........ 337
Mebendazole ........................................................................... 3180 Methanesulfonic acid, methyl, ethyl and isopropyl

Mebeverine hydrochloride .................................................... 3181 methanesulfonate in (2.5.37.)................................................ 182
Meclozine dihydrochloride.................................................... 3183 Methanesulfonyl chloride in methanesulfonic acid
Medicated chewing gums ........................................................ 907 (2.5.39.) .................................................................................... 184
Medicated chewing gums, dissolution test for (2.9.25.)....... 365 Methanol.................................................................................. 3222
Medicated feeding stuffs for veterinary use, premixes for .. 927 Methanol and 2-propanol, test for (2.9.11.) .......................... 342
Medicated foams....................................................................... 911 Methenamine .......................................................................... 3223
Medicated plasters .................................................................... 936 Methionine .............................................................................. 3223
Medicated tampons .................................................................. 940 Methionine ([11C]methyl) injection, L- ................................ 1220
Medicated vaginal tampons..................................................... 941 Methionine, DL- ...................................................................... 3225
Medicinal air ........................................................................... 1768 Methods in pharmacognosy (2.8.).......................................... 305
Medicinal air, synthetic.......................................................... 1770 Methods of preparation of homoeopathic stocks and
Medium-chain triglycerides .................................................. 4096 potentisation ......................................................................... 1682
Medronic acid for radiopharmaceutical preparations ....... 1219 Methods of preparation of sterile products (5.1.1.) ............. 619
Medroxyprogesterone acetate................................................ 3184 Methotrexate ........................................................................... 3225
Mefenamic acid....................................................................... 3186 Methyl, ethyl and isopropyl benzenesulfonate in active
Mefloquine hydrochloride..................................................... 3187 substances (2.5.41.)................................................................. 186
Megestrol acetate .................................................................... 3189 Methyl, ethyl and isopropyl methanesulfonate in active
Meglumine............................................................................... 3191 substances (2.5.38.)................................................................. 183
Meldonium dihydrate............................................................. 3192 Methyl, ethyl and isopropyl methanesulfonate in
Melilot ...................................................................................... 1534 methanesulfonic acid (2.5.37.) .............................................. 182
Melissa leaf .............................................................................. 1536 Methyl, ethyl and isopropyl toluenesulfonate in active
Melissa leaf dry extract .......................................................... 1537 substances (2.5.40.)................................................................. 185
Meloxicam ............................................................................... 3193 Methyl methacrylate – methacrylic acid copolymer (1:1).. 3217
Melphalan ................................................................................ 3194 Methyl methacrylate - methacrylic acid copolymer (1:2).. 3218
Melting point - capillary method (2.2.14.) .............................. 32 Methyl nicotinate.................................................................... 3228
Melting point - instantaneous method (2.2.16.) ..................... 33 Methyl parahydroxybenzoate................................................ 3229
Melting point - open capillary method (2.2.15.) .................... 33 Methyl parahydroxybenzoate, sodium................................. 3830
Menadione............................................................................... 3196 Methyl salicylate ..................................................................... 3230
Meningococcal group A, C, W135 and Y conjugate Methylcellulose ....................................................................... 3231
vaccine ................................................................................... 1009 Methyldopa.............................................................................. 3233
Meningococcal group C and haemophilus type b conjugate Methylene blue........................................................................ 3250
vaccine ..................................................................................... 979 Methylene chloride................................................................. 3235
Meningococcal group C conjugate vaccine ......................... 1010 Methylergometrine maleate .................................................. 3236
Meningococcal polysaccharide vaccine ............................... 1012 Methylhydroxyethylcellulose................................................. 3237
Menthol, racemic .................................................................... 3197 Methylpentoses in polysaccharide vaccines (2.5.21.) ........... 173
Mepivacaine hydrochloride ................................................... 3198 Methylphenidate hydrochloride ........................................... 3238
Meprobamate .......................................................................... 3200 Methylphenobarbital .............................................................. 3239
Mepyramine maleate.............................................................. 3200 Methylprednisolone................................................................ 3240
Mercaptopurine ...................................................................... 3201 Methylprednisolone acetate................................................... 3243
Mercuric chloride ................................................................... 3202 Methylprednisolone hydrogen succinate ............................. 3245
Mercury porosimetry, porosity and pore-size distribution of Methylpyrrolidone, N- ........................................................... 3246
solids by (2.9.32.).................................................................... 377 Methylrosanilinium chloride ................................................ 3247
Meropenem trihydrate ........................................................... 3203 Methyltestosterone ................................................................. 3249
Mesalazine ............................................................................... 3204 Methylthioninium chloride hydrate ..................................... 3250
Mesna ....................................................................................... 3207 Metixene hydrochloride......................................................... 3251
Mesterolone ............................................................................. 3208 Metoclopramide...................................................................... 3252
Mestranol ................................................................................. 3209 Metoclopramide hydrochloride monohydrate.................... 3253
Metabisulfite, potassium ........................................................ 3607 Metolazone .............................................................................. 3255
Metabisulfite, sodium............................................................. 3829 Metoprolol succinate .............................................................. 3256
Metacresol................................................................................ 3210 Metoprolol tartrate ................................................................. 3258
Metal catalyst or metal reagent residues (5.20.).................... 815 Metrifonate .............................................................................. 3259
Metal catalyst or metal reagent residues, determination of Metronidazole ......................................................................... 3261
(2.4.20.) .................................................................................... 144 Metronidazole benzoate......................................................... 3262
Metamizole sodium monohydrate........................................ 3211 Mexiletine hydrochloride ...................................................... 3263
Metered-dose preparations for inhalation, non- Mianserin hydrochloride ....................................................... 3264
pressurised............................................................................... 930 Miconazole .............................................................................. 3266
Metered-dose preparations for inhalation, pressurised ....... 928 Miconazole nitrate.................................................................. 3267
Metformin hydrochloride...................................................... 3213 Micro determination of water (2.5.32.).................................. 178
Methacrylate copolymer, basic butylated ............................ 1925 Microbial enumeration tests (microbiological examination of
Methacrylic acid - ethyl acrylate copolymer (1:1).............. 3214 non-sterile products) (2.6.12.) .............................................. 201
Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion Microbiological assay of antibiotics (2.7.2.) .......................... 262
30 per cent ............................................................................. 3216 Microbiological examination of cell-based preparations
Methacrylic acid - methyl methacrylate copolymer (1:1).. 3217 (2.6.27.) .................................................................................... 231
Methacrylic acid - methyl methacrylate copolymer (1:2).. 3218 Microbiological examination of herbal medicinal products for
Methadone hydrochloride ..................................................... 3219 oral use and extracts used in their preparation (2.6.31.)... 239
Methane ................................................................................... 3220 Microbiological examination of live biotherapeutic
Methane intermix (2 per cent) in nitrogen ......................... 3221 products : tests for enumeration of microbial contaminants
Methanesulfonate (methyl, ethyl and isopropyl) in active (2.6.36.) .................................................................................... 250
substances (2.5.38.)................................................................. 183 Microbiological examination of live biotherapeutic products :
Methanesulfonic acid, methanesulfonyl chloride in tests for specified micro-organisms (2.6.38.) ...................... 255
(2.5.39.) .................................................................................... 184 Microbiological examination of non-sterile products :
microbial enumeration tests (2.6.12.) .................................. 201

Microbiological examination of non-sterile products : test for Mycoplasma gallisepticum vaccine (inactivated) ............... 1129
specified micro-organisms (2.6.13.) ..................................... 205 Mycoplasmas (2.6.7.)................................................................ 194
Microbiological quality, alternative methods for control of myo-Inositol ............................................................................ 2944
(5.1.6.) ...................................................................................... 628 Myrrh ....................................................................................... 1546
Microbiological quality of herbal medicinal products for oral Myrrh tincture ........................................................................ 1547
use and extracts used in their preparation (5.1.8.)............. 638 Myxomatosis vaccine (live) for rabbits ................................ 1131
Microbiological quality of non-sterile pharmaceutical
preparations and substances for pharmaceutical use N
(5.1.4.) ...................................................................................... 627 Nabumetone ............................................................................ 3317
Microbiology, general texts on (5.1.) ..................................... 619 N-Acetyltryptophan ............................................................... 1755
Microcalorimetry and solution calorimetry, characterisation N-Acetyltyrosine ..................................................................... 1757
of crystalline solids by (2.2.61.) ............................................ 115 Nadolol..................................................................................... 3318
Microcrystalline cellulose ...................................................... 2146 Nadroparin calcium ............................................................... 3319
Microcrystalline cellulose and carmellose sodium ............ 3269 Naftidrofuryl hydrogen oxalate ............................................ 3322
Microscopic examination of herbal drugs (2.8.23) .............. 317 Nalidixic acid .......................................................................... 3323
Microscopy, optical (2.9.37.) ................................................... 390 Naloxone hydrochloride dihydrate....................................... 3325
Microscopy, scanning electron (2.9.52.) ................................ 414 Naltrexone hydrochloride...................................................... 3327
Midazolam............................................................................... 3270 Names of herbal drugs used in traditional Chinese medicine
Milbemycin oxime for veterinary use .................................. 3272 (5.22.) ....................................................................................... 839
Milk thistle dry extract, refined and standardised ............. 1538 Nandrolone decanoate ........................................................... 3328
Milk thistle fruit...................................................................... 1539 Naphazoline hydrochloride ................................................... 3330
Minimising the risk of transmitting animal spongiform Naphazoline nitrate ................................................................ 3331
encephalopathy agents via human and veterinary medicinal Naproxen ................................................................................. 3333
products (5.2.8.)...................................................................... 661 Naproxen sodium ................................................................... 3335
Minocycline hydrochloride dihydrate.................................. 3275 Narrow-leaved coneflower root ............................................ 1548
Minoxidil ................................................................................. 3277 Nasal drops and liquid nasal sprays ....................................... 919
Mint oil, partly dementholised ............................................. 1541 Nasal powders ........................................................................... 920
Mirtazapine ............................................................................. 3278 Nasal preparations .................................................................... 918
Misoprostol.............................................................................. 3279 Nasal preparations, semi-solid................................................ 920
Mites for allergen products ................................................... 3281 Nasal sprays (liquid) and nasal drops .................................... 918
Mitomycin ............................................................................... 3282 Nasal sticks ................................................................................ 920
Mitoxantrone hydrochloride ................................................. 3283 Nasal washes.............................................................................. 920
Modafinil ................................................................................. 3285 Nateglinide .............................................................................. 3337
Modified-release capsules ........................................................ 907 Near-infrared spectroscopy (2.2.40.)........................................ 70
Modified-release granules........................................................ 912 Nebulisation, characterisation of preparations for
Modified-release tablets ........................................................... 939 (2.9.44.) .................................................................................... 404
Mofetil mycophenolate .......................................................... 3312 Nebulisation, liquid preparations for ..................................... 928
Molecular mass distribution in dextrans (2.2.39.).................. 68 Neohesperidin-dihydrochalcone .......................................... 3339
Molgramostim concentrated solution.................................. 3286 Neomycin sulfate .................................................................... 3340
Molsidomine ........................................................................... 3288 Neonatal piglet colibacillosis vaccine (inactivated)............ 1132
Molybdate dihydrate, sodium ............................................... 3831 Neonatal ruminant colibacillosis vaccine (inactivated)..... 1133
Mometasone furoate............................................................... 3290 Neostigmine bromide............................................................. 3342
Mometasone furoate monohydrate ...................................... 3293 Neostigmine metilsulfate ....................................................... 3343
Monoclonal antibodies for human use .................................. 878 Neroli oil .................................................................................. 1550
Monocyte-activation test (2.6.30.).......................................... 233 Netilmicin sulfate.................................................................... 3344
Monographs on herbal drug extracts (information chapter) Nettle leaf................................................................................. 1551
(5.23.) ....................................................................................... 843 Nettle root................................................................................ 1553
Monophosphoryl lipid A, 3-O-desacyl-4′- .......................... 2355 Neurovirulence test of live viral vaccines (2.6.18.)............... 218
Montelukast sodium............................................................... 3295 Nevirapine ............................................................................... 3346
Morantel hydrogen tartrate for veterinary use ................... 3298 Nevirapine hemihydrate ........................................................ 3347
Morphine hydrochloride ....................................................... 3299 Newcastle disease vaccine (inactivated)............................... 1134
Morphine sulfate..................................................................... 3300 Newcastle disease vaccine (live)............................................ 1136
Moss, Iceland........................................................................... 1480 Niaouli oil, cineole type ......................................................... 1554
Mother tinctures for homoeopathic preparations .............. 1681 Nicardipine hydrochloride .................................................... 3348
Motherwort ............................................................................. 1542 Nicergoline .............................................................................. 3349
Moulds for allergen products ................................................ 3302 Nickel in hydrogenated vegetable oils (2.4.31.) .................... 163
Moutan bark............................................................................ 1543 Nickel in polyols (2.4.15.) ........................................................ 143
Mouthwashes............................................................................. 921 Niclosamide............................................................................. 3351
Moxidectin for veterinary use............................................... 3303 Niclosamide monohydrate .................................................... 3352
Moxifloxacin hydrochloride .................................................. 3306 Nicorandil................................................................................ 3353
Moxonidine ............................................................................. 3308 Nicotinamide........................................................................... 3354
Mucoadhesive preparations..................................................... 922 Nicotine.................................................................................... 3355
Mullein flower ......................................................................... 1545 Nicotine ditartrate dihydrate................................................. 3356
Multidose containers, uniformity of mass of delivered doses Nicotine resinate ..................................................................... 3357
(2.9.27.) .................................................................................... 372 Nicotinic acid .......................................................................... 3359
Mumps, measles and rubella vaccine (live)......................... 1005 Nifedipine ................................................................................ 3360
Mumps, measles, rubella and varicella vaccine (live) ........ 1006 Niflumic acid........................................................................... 3362
Mumps vaccine (live) ............................................................. 1014 Nifuroxazide............................................................................ 3363
Mupirocin ................................................................................ 3309 Nikethamide............................................................................ 3364
Mupirocin calcium ................................................................. 3310 Nilotinib hydrochloride monohydrate................................. 3365
Mycobacteria (2.6.2.)................................................................ 194 Nilutamide............................................................................... 3367
Mycophenolate mofetil .......................................................... 3312 Nimesulide............................................................................... 3368
Mycophenolate sodium.......................................................... 3314
Nimodipine ............................................................................. 3369 Oils, fatty, identification by thin-layer chromatography

Nitrazepam .............................................................................. 3371 (2.3.2.) ...................................................................................... 132
Nitrendipine ............................................................................ 3372 Oils, fatty, vegetable.................................................................. 901
Nitric acid ................................................................................ 3373 Oils rich in omega-3 acids, composition of fatty acids in
Nitric oxide.............................................................................. 3373 (2.4.29.) .................................................................................... 161
Nitrofural ................................................................................. 3374 Oils rich in omega-3 acids, total cholesterol in (2.4.32.) ..... 163
Nitrofurantoin......................................................................... 3375 Ointments .................................................................................. 936
Nitrogen ................................................................................... 3376 Olanzapine............................................................................... 3410
Nitrogen determination by sulfuric acid digestion (2.5.9.).. 170 Oleic acid ................................................................................. 3411
Nitrogen determination, primary aromatic amino (2.5.8.).. 169 Oleoresins .................................................................................. 868
Nitrogen, low-oxygen............................................................. 3377 Oleoyl macrogolglycerides .................................................... 3411
Nitrogen monoxide and nitrogen dioxide in gases Oleyl alcohol............................................................................ 3412
(2.5.26.) .................................................................................... 176 Olive leaf .................................................................................. 1557
Nitroprusside, sodium ........................................................... 3832 Olive leaf dry extract .............................................................. 1559
Nitrous oxide........................................................................... 3377 Olive oil, refined ..................................................................... 3413
Nitrous oxide in gases (2.5.35.)............................................... 182 Olive oil, virgin ....................................................................... 3414
Nizatidine ................................................................................ 3379 Olmesartan medoxomil ......................................................... 3415
N-Methylpyrrolidone ............................................................. 3246 Olsalazine sodium .................................................................. 3417
NMR spectrometry (2.2.33.) ..................................................... 58 Omega-3 acids, composition of fatty acids in oils rich in
NMR spectrometry, peptide identification by (2.2.64.)....... 118 (2.4.29.) .................................................................................... 161
N,N-Dimethylaniline (2.4.26.) ................................................ 158 Omega-3 acids, fish oil rich in .............................................. 2639
Nomegestrol acetate ............................................................... 3381 Omega-3 acids, total cholesterol in oils rich in (2.4.32.) ..... 163
Nonoxinol 9............................................................................. 3381 Omega-3-acid ethyl esters 60 ................................................ 3419
Non-sterile pharmaceutical preparations and substances for Omega-3-acid ethyl esters 90 ................................................ 3421
pharmaceutical use, microbiological quality of (5.1.4.)..... 627 Omega-3-acid triglycerides ................................................... 3423
Non-sterile products, microbiological examination of Omeprazole ............................................................................. 3425
(microbial enumeration tests) (2.6.12.) ............................... 201 Omeprazole magnesium ........................................................ 3427
Non-sterile products, microbiological examination of (test for Omeprazole sodium ............................................................... 3428
specified micro-organisms) (2.6.13.).................................... 205 Ondansetron hydrochloride dihydrate ................................ 3430
Noradrenaline hydrochloride................................................ 3382 Opalescence of liquids, clarity and degree of (2.2.1.)............. 21
Noradrenaline tartrate ........................................................... 3384 Ophthalmic inserts ................................................................... 910
Norepinephrine hydrochloride ............................................. 3382 Opium dry extract, standardised.......................................... 1560
Norepinephrine tartrate......................................................... 3384 Opium, prepared .................................................................... 1561
Norethisterone ........................................................................ 3385 Opium, raw.............................................................................. 1562
Norethisterone acetate ........................................................... 3387 Opium tincture, standardised ............................................... 1564
Norfloxacin.............................................................................. 3388 Optical microscopy (2.9.37.) ................................................... 390
Norflurane ............................................................................... 3390 Optical rotation (2.2.7.) ............................................................. 26
Norgestimate ........................................................................... 3396 Oral drops.................................................................................. 918
Norgestrel ................................................................................ 3397 Oral lyophilisates ...................................................................... 939
Normal immunoglobulin for intramuscular administration, Oral powders............................................................................. 926
human .................................................................................... 2860 Oral solutions, emulsions and suspensions........................... 917
Normal immunoglobulin for intravenous administration, Oral use, liquid preparations for ............................................ 916
human .................................................................................... 2862 Oral use, veterinary semi-solid preparations for .................. 942
Normal immunoglobulin for subcutaneous administration, Orbifloxacin for veterinary use............................................. 3431
human .................................................................................... 2864 Orciprenaline sulfate .............................................................. 3433
Nortriptyline hydrochloride.................................................. 3397 Oregano ................................................................................... 1565
Noscapine ................................................................................ 3399 Organ preservation, solutions for......................................... 3852
Noscapine hydrochloride hydrate......................................... 3400 Oriental cashew for homoeopathic preparations ............... 1702
Notoginseng root .................................................................... 1555 Orientvine stem ...................................................................... 1567
Nuclear magnetic resonance spectrometry (2.2.33.).............. 58 Orodispersible films ................................................................. 922
Nuclear magnetic resonance spectrometry, peptide Orodispersible tablets .............................................................. 939
identification by (2.2.64.)....................................................... 118 Oromucosal capsules................................................................ 922
Nucleated cell count and viability (2.7.29.) ........................... 297 Oromucosal drops, oromucosal sprays and sublingual
Nucleic acid amplification techniques (2.6.21.) .................... 219 sprays........................................................................................ 921
Nucleic acids in polysaccharide vaccines (2.5.17.) ............... 172 Oromucosal preparations ........................................................ 920
Numeration of CD34/CD45+ cells in haematopoietic products Oromucosal preparations, semi-solid .................................... 921
(2.7.23.) .................................................................................... 292 Oromucosal solutions and oromucosal suspensions............ 921
Nutmeg oil ............................................................................... 1556 Oromucosal sprays, oromucosal drops and sublingual
Nux-vomica for homoeopathic preparations ...................... 1723 sprays........................................................................................ 920
Nystatin.................................................................................... 3401 Oromucosal suspensions and oromucosal solutions............ 920
Orphenadrine citrate.............................................................. 3434
O Orphenadrine hydrochloride ................................................ 3436
O-Acetyl in polysaccharide vaccines (2.5.19.)....................... 173 Oseltamivir phosphate ........................................................... 3437
Oak bark .................................................................................. 1557 Osmolality (2.2.35.) .................................................................... 63
Octoxinol 10............................................................................ 3405 Ouabain ................................................................................... 3439
Octreotide................................................................................ 3405 Oxacillin sodium monohydrate ............................................ 3440
Octyl gallate............................................................................. 3407 Oxaliplatin ............................................................................... 3442
Octyldodecanol ....................................................................... 3407 Oxazepam ................................................................................ 3445
Odour (2.3.4.)............................................................................ 133 Oxcarbazepine......................................................................... 3446
Odour and taste of essential oils (2.8.8.)................................ 306 Oxeladin hydrogen citrate ..................................................... 3448
Ofloxacin.................................................................................. 3408 Oxfendazole for veterinary use ............................................. 3449
Oils, essential............................................................................. 864 Oxidising substances (2.5.30.)................................................. 177
Oxitropium bromide .............................................................. 3450

Oxolinic acid ........................................................................... 3451 Particulate contamination : visible particles (2.9.20.)........... 362
Oxybuprocaine hydrochloride .............................................. 3453 Parvovirosis vaccine (inactivated), canine........................... 1085
Oxybutynin hydrochloride .................................................... 3454 Parvovirosis vaccine (inactivated), porcine......................... 1143
Oxycodone hydrochloride ..................................................... 3455 Parvovirosis vaccine (live), canine........................................ 1086
Oxygen ..................................................................................... 3456 Passion flower ......................................................................... 1570
Oxygen (15O) ........................................................................... 1222 Passion flower dry extract ..................................................... 1571
Oxygen (93 per cent).............................................................. 3457 Pastes .......................................................................................... 936
Oxygen in gases (2.5.27.) ......................................................... 176 Pasteurella vaccine (inactivated) for sheep.......................... 1138
Oxygen-flask method (2.5.10.)................................................ 170 Pastilles and lozenges ............................................................... 922
Oxymetazoline hydrochloride............................................... 3459 Patches, cutaneous.................................................................... 935
Oxytetracycline dihydrate...................................................... 3460 Patches, transdermal ................................................................ 925
Oxytetracycline hydrochloride.............................................. 3462 Patches, transdermal, dissolution test for (2.9.4.)................. 333
Oxytocin .................................................................................. 3464 Pea starch................................................................................. 3492
Oxytocin concentrated solution............................................ 3465 Pefloxacin mesilate dihydrate................................................ 3493
Pelargonium root .................................................................... 1571
P Pemetrexed disodium heptahydrate..................................... 3494
Paclitaxel .................................................................................. 3469 Penbutolol sulfate ................................................................... 3497
Pale coneflower root............................................................... 1568 Penetrometry, measurement of consistency by (2.9.9.) ....... 337
Palmitic acid............................................................................ 3473 Penicillamine........................................................................... 3498
Pamidronate disodium pentahydrate................................... 3474 Penicillin G (benzathine) tetrahydrate................................. 1951
Pancreas powder ..................................................................... 3474 Penicillin G potassium ........................................................... 1953
Pancreatic necrosis vaccine (inactivated, oil-adjuvanted, Penicillin G (procaine) monohydrate .................................. 1955
injectable) for salmonids, infectious .................................. 1124 Penicillin G sodium................................................................ 1957
Pancuronium bromide ........................................................... 3477 Penicillin V .............................................................................. 3530
Panleucopenia vaccine (inactivated), feline ........................ 1109 Penicillin V (benzathine) tetrahydrate................................. 3531
Panleucopenia vaccine (live), feline ..................................... 1110 Penicillin V potassium ........................................................... 3533
Pansy, wild (flowering aerial parts)...................................... 1668 Pentaerythrityl tetranitrate, diluted...................................... 3499
Pantoprazole sodium sesquihydrate..................................... 3478 Pentamidine diisetionate ....................................................... 3501
Pantothenate, calcium ............................................................ 2063 Pentazocine.............................................................................. 3502
Papaverine hydrochloride...................................................... 3480 Pentazocine hydrochloride .................................................... 3502
Paper chromatography (2.2.26.) ............................................... 46 Pentazocine lactate ................................................................. 3503
Papillomavirus vaccine (rDNA), human .............................. 989 Pentetate sodium calcium for radiopharmaceutical
Paraben, butyl ......................................................................... 2025 preparations .......................................................................... 1223
Paraben, ethyl.......................................................................... 2583 Pentobarbital ........................................................................... 3504
Paraben, methyl ...................................................................... 3229 Pentobarbital sodium ............................................................. 3505
Paraben, propyl ....................................................................... 3660 Pentoxifylline .......................................................................... 3507
Paraben, sodium ethyl............................................................ 3816 Pentoxyverine hydrogen citrate ............................................ 3509
Paraben, sodium methyl ........................................................ 3830 Peony root, red........................................................................ 1572
Paraben, sodium propyl......................................................... 3838 Peony root, white .................................................................... 1573
Paracetamol ............................................................................. 3481 Pepper ...................................................................................... 1575
Paraffin, hard........................................................................... 3483 Pepper, long............................................................................. 1510
Paraffin, light liquid ............................................................... 3483 Peppermint leaf....................................................................... 1577
Paraffin, liquid ........................................................................ 3484 Peppermint leaf dry extract................................................... 1578
Paraffin, white soft.................................................................. 3485 Peppermint oil ........................................................................ 1579
Paraffin, yellow soft ................................................................ 3486 Pepsin powder......................................................................... 3509
Parahydroxybenzoate, butyl .................................................. 2025 Peptide identification by nuclear magnetic resonance
Parahydroxybenzoate, ethyl .................................................. 2583 spectrometry (2.2.64.)............................................................ 118
Parahydroxybenzoate, methyl ............................................... 3229 Peptide mapping (2.2.55.).......................................................... 97
Parahydroxybenzoate, propyl................................................ 3660 Peptides, synthetic, acetic acid in (2.5.34.) ............................ 181
Parahydroxybenzoate, sodium ethyl .................................... 3816 Perborate, hydrated sodium .................................................. 3833
Parahydroxybenzoate, sodium methyl................................. 3830 Pergolide mesilate................................................................... 3511
Parahydroxybenzoate, sodium propyl.................................. 3838 Perindopril tert-butylamine .................................................. 3512
Parainfluenza virus vaccine (live), bovine ........................... 1073 Peritoneal dialysis, solutions for ........................................... 3515
Parainfluenza virus vaccine (live), canine ........................... 1084 Permethrin (25:75) ................................................................. 3517
Paraldehyde ............................................................................. 3486 Peroxide value (2.5.5.).............................................................. 168
Paramyxovirus 1 (Newcastle disease) vaccine (inactivated), Perphenazine........................................................................... 3519
avian ....................................................................................... 1134 Pertussis (acellular, component), diphtheria and tetanus
Paramyxovirus 1 (Newcastle disease) vaccine (live), vaccine (adsorbed) ................................................................. 955
avian ....................................................................................... 1136 Pertussis (acellular, component), diphtheria and tetanus
Paramyxovirus 3 vaccine (inactivated) for turkeys, avian.. 1068 vaccine (adsorbed, reduced antigen(s) content)................. 956
Parenteral preparations............................................................ 923 Pertussis (acellular, component), diphtheria, tetanus and
Parenteral preparations, test for extractable volume of haemophilus type b conjugate vaccine (adsorbed) ............ 961
(2.9.17.) .................................................................................... 347 Pertussis (acellular, component), diphtheria, tetanus and
Parnaparin sodium ................................................................. 3487 hepatitis B (rDNA) vaccine (adsorbed) ............................... 963
Paroxetine hydrochloride ...................................................... 3488 Pertussis (acellular, component), diphtheria, tetanus and
Paroxetine hydrochloride hemihydrate ............................... 3490 poliomyelitis (inactivated) vaccine (adsorbed)................... 964
Particle size analysis by laser light diffraction (2.9.31.)....... 373 Pertussis (acellular, component), diphtheria, tetanus and
Particles, fine, aerodynamic assessment of in preparations for poliomyelitis (inactivated) vaccine (adsorbed, reduced
inhalation (2.9.18.) ................................................................. 347 antigen(s) content) ................................................................. 966
Particle-size distribution estimation by analytical sieving Pertussis (acellular, component), diphtheria, tetanus,
(2.9.38.) .................................................................................... 392 hepatitis B (rDNA), poliomyelitis (inactivated) and
Particulate contamination : sub-visible particles (2.9.19.) ... 360 haemophilus type b conjugate vaccine (adsorbed) ............ 968
Pertussis (acellular, component), diphtheria, tetanus, Pillules, homoeopathic, coated ............................................. 1697
poliomyelitis (inactivated) and haemophilus type b conjugate Pillules, homoeopathic, impregnated................................... 1697
vaccine (adsorbed) ................................................................. 970 Pilocarpine hydrochloride ..................................................... 3559
Pertussis toxin (residual) (2.6.33.) .......................................... 241 Pilocarpine nitrate .................................................................. 3560
Pertussis vaccine (acellular), assay of (2.7.16.)...................... 286 Pimobendan for veterinary use............................................. 3561
Pertussis vaccine (acellular, component, adsorbed)........... 1015 Pimozide .................................................................................. 3562
Pertussis vaccine (acellular, co-purified, adsorbed) ........... 1016 Pindolol.................................................................................... 3563
Pertussis vaccine (whole cell, adsorbed).............................. 1018 Pine (dwarf) oil....................................................................... 1419
Pertussis vaccine (whole cell), assay of (2.7.7.) ..................... 274 Pine sylvestris oil .................................................................... 1581
Pertussis (whole cell), diphtheria and tetanus vaccine Pioglitazone hydrochloride ................................................... 3565
(adsorbed) ............................................................................... 958 Pipemidic acid trihydrate ...................................................... 3566
Pertussis (whole cell), diphtheria, tetanus and poliomyelitis Piperacillin............................................................................... 3567
(inactivated) vaccine (adsorbed) .......................................... 973 Piperacillin sodium ................................................................ 3568
Pertussis (whole cell), diphtheria, tetanus, poliomyelitis Piperazine adipate .................................................................. 3570
(inactivated) and haemophilus type b conjugate vaccine Piperazine citrate .................................................................... 3571
(adsorbed) ............................................................................... 974 Piperazine hydrate .................................................................. 3572
Peru balsam ............................................................................. 1580 Piracetam ................................................................................. 3573
Pessaries ..................................................................................... 940 Pirenzepine dihydrochloride monohydrate ........................ 3574
Pessaries and suppositories, disintegration of (2.9.2.) ......... 325 Piretanide................................................................................. 3575
Pesticide residues (2.8.13.)....................................................... 308 Pirfenidone .............................................................................. 3576
Pethidine hydrochloride ........................................................ 3520 Piroxicam................................................................................. 3577
Petroleum rectificatum for homoeopathic preparations ... 1725 Pivampicillin ........................................................................... 3579
pH of solutions, approximate (2.2.4.)....................................... 25 Pivmecillinam hydrochloride................................................ 3581
pH, potentiometric determination of (2.2.3.) ......................... 24 Plasma for fractionation, human.......................................... 2865
Pharmaceutical preparations................................................... 880 Plasma (pooled and treated for virus inactivation),
Pharmaceutical technical procedures (2.9.) .......................... 323 human .................................................................................... 2867
Pharmacognosy, methods in (2.8.)......................................... 305 Plasmid vectors for human use, bacterial cells used for the
Pharmacopoeial harmonisation (5.8.) ................................... 755 manufacture of........................................................................ 781
Phenazone................................................................................ 3522 Plasmin inhibitor, assay of human (2.7.25.).......................... 295
Pheniramine maleate.............................................................. 3523 Plasters, medicated ................................................................... 935
Phenobarbital .......................................................................... 3524 Plastic additives (3.1.13.) ......................................................... 441
Phenobarbital sodium............................................................ 3525 Plastic containers and closures for pharmaceutical use
Phenol ...................................................................................... 3527 (3.2.2.) ...................................................................................... 459
Phenol in immunosera and vaccines (2.5.15.) ...................... 172 Plastic containers for aqueous solutions for infusion
Phenolphthalein...................................................................... 3527 (3.2.2.1.) ................................................................................... 460
Phenolsulfonphthalein ........................................................... 3528 Plastic containers for human blood and blood components,
Phenothiazines, identification by thin-layer chromatography sterile (3.3.4.)........................................................................... 471
(2.3.3.) ...................................................................................... 133 Plastic syringes, single-use, sterile (3.3.8.)............................. 477
Phenoxyethanol ...................................................................... 3529 Platycodon root....................................................................... 1582
Phenoxymethylpenicillin ....................................................... 3530 Pneumococcal polysaccharide conjugate vaccine
Phenoxymethylpenicillin (benzathine) tetrahydrate.......... 3531 (adsorbed) ............................................................................. 1019
Phenoxymethylpenicillin potassium .................................... 3533 Pneumococcal polysaccharide vaccine ................................ 1021
Phentolamine mesilate ........................................................... 3535 Pneumonia vaccine (inactivated), porcine enzootic .......... 1141
Phenylalanine .......................................................................... 3536 Podophyllotoxin...................................................................... 3582
Phenylbutazone....................................................................... 3538 Poliomyelitis (inactivated), diphtheria and tetanus vaccine
Phenylbutyrate, sodium ......................................................... 3833 (adsorbed, reduced antigen(s) content)............................... 959
Phenylephrine ......................................................................... 3539 Poliomyelitis (inactivated), diphtheria, tetanus and pertussis
Phenylephrine hydrochloride................................................ 3541 (acellular, component) vaccine (adsorbed)......................... 964
Phenylmercuric acetate.......................................................... 3542 Poliomyelitis (inactivated), diphtheria, tetanus and pertussis
Phenylmercuric borate........................................................... 3542 (acellular, component) vaccine (adsorbed, reduced antigen(s)
Phenylmercuric nitrate .......................................................... 3543 content).................................................................................... 966
Phenylpropanolamine hydrochloride .................................. 3543 Poliomyelitis (inactivated), diphtheria, tetanus and pertussis
Phenytoin................................................................................. 3545 (whole cell) vaccine (adsorbed) ............................................ 973
Phenytoin sodium................................................................... 3546 Poliomyelitis (inactivated), diphtheria, tetanus, pertussis
Phloroglucinol......................................................................... 3548 (acellular, component) and haemophilus type b conjugate
Phloroglucinol dihydrate ....................................................... 3549 vaccine (adsorbed) ................................................................. 970
Pholcodine monohydrate ...................................................... 3551 Poliomyelitis (inactivated), diphtheria, tetanus, pertussis
Phosphates (2.4.11.).................................................................. 142 (acellular, component), hepatitis B (rDNA) and haemophilus
Phospholipids for injection, egg ........................................... 2494 type b conjugate vaccine (adsorbed).................................... 968
Phospholipids for injection, soya.......................................... 3870 Poliomyelitis (inactivated), diphtheria, tetanus, pertussis
Phosphoric acid, concentrated.............................................. 3553 (whole cell) and haemophilus type b conjugate vaccine
Phosphoric acid, dilute .......................................................... 3553 (adsorbed) ............................................................................... 974
Phosphorus in polysaccharide vaccines (2.5.18.) ................. 172 Poliomyelitis vaccine (inactivated) ....................................... 1023
Phthalylsulfathiazole .............................................................. 3553 Poliomyelitis vaccine (inactivated), in vivo assay of
Physical and physico-chemical methods (2.2.) ....................... 21 (2.7.20.) .................................................................................... 289
Physostigmine salicylate ........................................................ 3554 Poliomyelitis vaccine (oral) ................................................... 1026
Phytomenadione, racemic ..................................................... 3555 Pollens for allergen products................................................. 3583
Phytonadione, racemic........................................................... 3555 Poloxamers .............................................................................. 3584
Phytosterol............................................................................... 3557 Polyacrylate dispersion 30 per cent...................................... 3586
Picosulfate, sodium ................................................................ 3835 Polyamide suture, sterile, in distributor for veterinary
Picotamide monohydrate....................................................... 3558 use........................................................................................... 1282
Piglet colibacillosis vaccine (inactivated), neonatal ........... 1132 Poly(ethylene - vinyl acetate) for containers and tubing for
Pillules for homoeopathic preparations............................... 1696 total parenteral nutrition preparations (3.1.7.)................... 434

Polyethylene oxides, high-molecular-mass ......................... 3147 Porosity and pore-size distribution of solids by mercury
Polyethylene terephthalate for containers for preparations not porosimetry (2.9.32.).............................................................. 377
for parenteral use (3.1.15.) .................................................... 448 Porosity of sintered-glass filters (2.1.2.)................................... 15
Poly(ethylene terephthalate) suture, sterile, in distributor for Porous solids including powders, wettability of (2.9.45.) .... 406
veterinary use........................................................................ 1283 Potassium (2.4.12.) ................................................................... 142
Polyethylene with additives for containers for parenteral Potassium acetate.................................................................... 3596
preparations and for ophthalmic preparations (3.1.5.)...... 427 Potassium bromide................................................................. 3597
Polyethylene without additives for containers for parenteral Potassium carbonate............................................................... 3598
preparations and for ophthalmic preparations (3.1.4.)...... 426 Potassium chloride ................................................................. 3598
Polyethyleneglycols................................................................. 3145 Potassium citrate..................................................................... 3599
Polyethyleneglycols, high-molecular-mass.......................... 3147 Potassium clavulanate ............................................................ 3599
Polygonum cuspidatum rhizome and root.......................... 1583 Potassium clavulanate, diluted.............................................. 3602
Polygonum orientale fruit ..................................................... 1585 Potassium dichromate for homoeopathic preparations..... 1721
Polymorphism (5.9.)................................................................. 759 Potassium dihydrogen phosphate......................................... 3603
Polymyxin B sulfate ................................................................ 3587 Potassium disulfite.................................................................. 3607
Polyolefins (3.1.3.) .................................................................... 423 Potassium hydrogen aspartate hemihydrate ....................... 3604
Polyoxyl castor oil................................................................... 3144 Potassium hydrogen carbonate ............................................. 3605
Polyoxyl hydrogenated castor oil .......................................... 3144 Potassium hydrogen tartrate ................................................. 3605
Polyoxypropylene stearyl ether ............................................. 3588 Potassium hydroxide .............................................................. 3606
Polypropylene for containers and closures for parenteral Potassium iodide..................................................................... 3606
preparations and ophthalmic preparations (3.1.6.)............ 431 Potassium metabisulfite ......................................................... 3607
Polysaccharide vaccines for human use, conjugated, carrier Potassium nitrate .................................................................... 3607
proteins for the production of (5.2.11.) ............................... 674 Potassium perchlorate............................................................ 3608
Polysaccharide vaccines, hexosamines in (2.5.20.)............... 173 Potassium permanganate....................................................... 3609
Polysaccharide vaccines, methylpentoses in (2.5.21.) .......... 173 Potassium sodium tartrate tetrahydrate .............................. 3609
Polysaccharide vaccines, nucleic acids in (2.5.17.) ............... 172 Potassium sorbate ................................................................... 3610
Polysaccharide vaccines, O-acetyl in (2.5.19.)....................... 173 Potassium sulfate .................................................................... 3610
Polysaccharide vaccines, phosphorus in (2.5.18.)................. 172 Potato starch............................................................................ 3611
Polysaccharide vaccines, protein in (2.5.16.)......................... 172 Potentiometric determination of ionic concentration using
Polysaccharide vaccines, ribose in (2.5.31.) .......................... 177 ion-selective electrodes (2.2.36.)............................................. 64
Polysaccharide vaccines, sialic acid in (2.5.23.) .................... 174 Potentiometric determination of pH (2.2.3.) .......................... 24
Polysaccharide vaccines, uronic acids in (2.5.22.) ................ 174 Potentiometric titration (2.2.20.).............................................. 35
Polysorbate 20 ......................................................................... 3589 Potentisation, methods of preparation of homoeopathic stocks
Polysorbate 40 ......................................................................... 3590 and.......................................................................................... 1682
Polysorbate 60 ......................................................................... 3591 Poultices..................................................................................... 936
Polysorbate 80 ......................................................................... 3591 Pour-on preparations ............................................................... 942
Polystyrene sulfonate, sodium .............................................. 3836 Povidone .................................................................................. 3612
Poly(vinyl acetate) .................................................................. 3593 Povidone, iodinated................................................................ 3615
Poly(vinyl acetate) dispersion 30 per cent ........................... 3594 Powder fineness (2.9.35.) ......................................................... 387
Poly(vinyl alcohol).................................................................. 3595 Powder flow (2.9.36.)................................................................ 387
Poly(vinyl alcohol) macrogol grafted copolymer ............... 3140 Powder flow properties by shear cell methods (2.9.49.) ...... 411
Poly(vinyl chloride) (non-plasticised) for containers for solid Powdered cellulose ................................................................. 2150
dosage forms for oral administration, materials based on Powders and granules for oral solutions and suspensions .. 917
(3.1.11.) .................................................................................... 439 Powders and granules for syrups ............................................ 918
Poly(vinyl chloride), non-plasticised, materials based on for Powders and tablets for rectal solutions and suspensions... 934
containers for non-injectable aqueous solutions (3.1.10.).. 437 Powders, bulk density and tapped density of (2.9.34.)......... 384
Poly(vinyl chloride), plasticised, empty sterile containers of, Powders, ear .............................................................................. 909
for human blood and blood components (3.3.5.) .............. 473 Powders, effervescent ............................................................... 927
Poly(vinyl chloride), plasticised, materials based on, for Powders for cutaneous application......................................... 925
containers for aqueous solutions for intravenous infusion Powders for eye drops and powders for eye lotions ............. 910
(3.1.14.) .................................................................................... 445 Powders for injections or infusions........................................ 924
Poly(vinyl chloride), plasticised, materials based on, for Powders for oral drops............................................................. 918
containers for human blood and blood components Powders, inhalation .................................................................. 931
(3.3.2.) ...................................................................................... 465 Powders, nasal........................................................................... 920
Poly(vinyl chloride), plasticised, materials based on, for Powders, oral ............................................................................. 926
tubing used in sets for the transfusion of blood and blood Powders, wettability of porous solids including (2.9.45.) .... 406
components (3.3.3.)................................................................ 468 Pramipexole dihydrochloride monohydrate ....................... 3615
Poly(vinyl chloride), plasticised, sterile containers of, for Prasugrel hydrochloride......................................................... 3617
human blood containing anticoagulant solution (3.3.6.) .. 474 Pravastatin sodium ................................................................. 3618
Poppy petals, red..................................................................... 1595 Prazepam ................................................................................. 3620
Porcine actinobacillosis vaccine (inactivated) .................... 1139 Praziquantel............................................................................. 3621
Porcine enzootic pneumonia vaccine (inactivated) ........... 1141 Prazosin hydrochloride.......................................................... 3622
Porcine influenza vaccine (inactivated) ............................... 1142 Precursors for radiopharmaceutical preparations,
Porcine insulin ........................................................................ 2957 chemical................................................................................... 863
Porcine parvovirosis vaccine (inactivated).......................... 1143 Prednicarbate .......................................................................... 3624
Porcine progressive atrophic rhinitis vaccine Prednisolone............................................................................ 3625
(inactivated) .......................................................................... 1144 Prednisolone acetate............................................................... 3627
Pore-size distribution of solids by mercury porosimetry, Prednisolone pivalate ............................................................. 3629
porosity and (2.9.32.) ............................................................. 377 Prednisolone sodium phosphate........................................... 3630
Poria ......................................................................................... 1587 Prednisone............................................................................... 3631
Porosimetry, mercury, porosity and pore-size distribution of Pregabalin ................................................................................ 3633
solids by (2.9.32.).................................................................... 377 Pregelatinised hydroxypropyl starch .................................... 3890
Pregelatinised starch............................................................... 3891
Prekallikrein activator (2.6.15.)............................................... 213 Pycnometric density of solids, gas (2.9.23.) .......................... 364
Premixes for medicated feeding stuffs for veterinary use ... 927 Pygeum africanum bark ........................................................ 1593
Preparations for inhalation ..................................................... 927 Pyrantel embonate.................................................................. 3673
Preparations for inhalation : aerodynamic assessment of fine Pyrazinamide .......................................................................... 3674
particles (2.9.18.) .................................................................... 347 Pyridostigmine bromide ........................................................ 3675
Preparations for irrigation....................................................... 932 Pyridoxine hydrochloride...................................................... 3676
Preparations for nebulisation : characterisation (2.9.44.) .... 404 Pyrimethamine ....................................................................... 3677
Preservative and anticoagulant solutions for human Pyrogens (2.6.8.) ....................................................................... 199
blood ...................................................................................... 1856 Pyrophosphate (sodium) decahydrate for radiopharmaceutical
Pressurised pharmaceutical preparations.............................. 933 preparations .......................................................................... 1241
Prilocaine................................................................................. 3635 Pyrrolidone.............................................................................. 3678
Prilocaine hydrochloride ....................................................... 3636
Primaquine diphosphate........................................................ 3637 Q
Primary aromatic amino-nitrogen, determination of Quality control of vaccines, substitution of in vivo method(s)
(2.5.8.) ...................................................................................... 169 by in vitro method(s) for the (5.2.14.) ................................. 679
Primary standards for volumetric solutions (4.2.1.) ............ 609 Quality of non-sterile pharmaceutical preparations and
Primidone ................................................................................ 3639 substances for pharmaceutical use, microbiological
Primula root ............................................................................ 1588 (5.1.4.) ...................................................................................... 627
Probenecid............................................................................... 3640 Quantification and characterisation of residual host-cell DNA
Procainamide hydrochloride................................................. 3641 (2.6.35.) .................................................................................... 248
Procaine benzylpenicillin monohydrate .............................. 1955 Quantified hawthorn leaf and flower liquid extract........... 1473
Procaine hydrochloride.......................................................... 3642 Quetiapine fumarate .............................................................. 3683
Procaine penicillin G monohydrate ..................................... 1955 Quillaia bark............................................................................ 1593
Process analytical technology (5.25.) ..................................... 855 Quinapril hydrochloride........................................................ 3685
Prochlorperazine maleate ...................................................... 3642 Quinidine sulfate .................................................................... 3687
Products of fermentation......................................................... 882 Quinine hydrochloride .......................................................... 3689
Products of recombinant DNA technology........................... 888 Quinine sulfate........................................................................ 3690
Products with risk of transmitting agents of animal spongiform
encephalopathies .................................................................... 884
R
Progenitor cells, human haematopoietic, colony-forming cell
assay for (2.7.28.) .................................................................... 296 Rabbit haemorrhagic disease vaccine (inactivated) ........... 1147
Progesterone............................................................................ 3644 Rabeprazole sodium ............................................................... 3695
Progressive atrophic rhinitis vaccine (inactivated), Rabeprazole sodium hydrate................................................. 3696
porcine ................................................................................... 1144 Rabies immunoglobulin, human .......................................... 2871
Proguanil hydrochloride........................................................ 3646 Rabies vaccine for human use prepared in cell cultures.... 1030
Proline...................................................................................... 3647 Rabies vaccine (inactivated) for veterinary use .................. 1148
Promazine hydrochloride ...................................................... 3649 Rabies vaccine (live, oral) for foxes and raccoon dogs ...... 1150
Promethazine hydrochloride................................................. 3649 Racecadotril............................................................................. 3698
Propacetamol hydrochloride................................................. 3651 Racementhol............................................................................ 3197
Propafenone hydrochloride................................................... 3652 Racemic camphor ................................................................... 2069
Propanol................................................................................... 3654 Racemic ephedrine hydrochloride ....................................... 2513
Propanol and methanol, 2-, test for (2.9.11.) ........................ 342 Racemic menthol .................................................................... 3197
Propantheline bromide .......................................................... 3655 Racephedrine hydrochloride................................................. 2513
Propofol ................................................................................... 3656 Raclopride ([11C]methoxy) injection.................................... 1224
Propranolol hydrochloride .................................................... 3658 Radioactivity, detection and measurement of (2.2.66.) ....... 119
Propyl gallate........................................................................... 3659 Radiolabelling, fluoride (18F) solution for ........................... 1194
Propyl parahydroxybenzoate................................................. 3660 Radiolabelling, gallium (68Ga) chloride solution for .......... 1206
Propyl parahydroxybenzoate, sodium ................................. 3838 Radiolabelling, lutetium (177Lu) solution for....................... 1218
Propylene glycol...................................................................... 3661 Radiolabelling, sodium iodide (123I) solution for................ 1228
Propylene glycol dicaprylocaprate........................................ 3662 Radiolabelling, sodium iodide (131I) solution for................ 1232
Propylene glycol dilaurate ..................................................... 3662 Radiolabelling, yttrium (90Y) chloride solution for ............ 1265
Propylene glycol monolaurate............................................... 3663 Radionuclides, table of physical characteristics (5.7.).......... 745
Propylene glycol monopalmitostearate................................ 3664 Radiopharmaceutical preparations ........................................ 884
Propylene glycol monostearate ............................................. 3664 Radiopharmaceutical preparations, chemical precursors
Propylthiouracil ...................................................................... 3665 for ............................................................................................. 863
Propyphenazone ..................................................................... 3666 Radiopharmaceutical preparations, copper tetramibi
Protamine sulfate.................................................................... 3667 tetrafluoroborate for............................................................. 1187
Protein assays, host-cell (2.6.34.)............................................ 244 Radiopharmaceutical preparations, iobenguane sulfate
Protein C, human, assay of (2.7.30.)....................................... 299 for ........................................................................................... 1216
Protein in polysaccharide vaccines (2.5.16.) ......................... 172 Radiopharmaceutical preparations, medronic acid for ..... 1219
Protein S, human, assay of (2.7.31.) ....................................... 300 Radiopharmaceutical preparations, pentetate sodium calcium
Protein, total (2.5.33.) .............................................................. 178 for ........................................................................................... 1223
Prothrombin complex, human.............................................. 2870 Radiopharmaceutical preparations, sodium iodohippurate
Protirelin.................................................................................. 3669 dihydrate for.......................................................................... 1234
Proxyphylline .......................................................................... 3670 Radiopharmaceutical preparations, sodium pyrophosphate
Pseudoephedrine hydrochloride........................................... 3671 decahydrate for ..................................................................... 1241
Psyllium seed........................................................................... 1588 Radiopharmaceutical preparations, tetra-O-acetyl-mannose
Pullulan.................................................................................... 3672 triflate for .............................................................................. 1261
Pulsed electrochemical detection and direct amperometric Radiopharmaceuticals, extemporaneous preparation of
detection (2.2.63.)................................................................... 117 (5.19.) ....................................................................................... 807
Purified water .......................................................................... 4207 Raloxifene hydrochloride ...................................................... 3699
Purple coneflower herb.......................................................... 1589 Raltegravir chewable tablets .................................................. 3702
Purple coneflower root .......................................................... 1591 Raltegravir potassium ............................................................ 3701

Raltegravir tablets ................................................................... 3704 Roselle ...................................................................................... 1600

Raman spectroscopy (2.2.48.) ................................................... 92 Rosemary leaf.......................................................................... 1601
Ramipril ................................................................................... 3705 Rosemary oil ........................................................................... 1603
Ramon assay, flocculation value (Lf) of diphtheria and tetanus Rosuvastatin calcium.............................................................. 3746
toxins and toxoids (2.7.27.) ................................................... 295 Rotating viscometer method - viscosity (2.2.10.) ................... 28
Ranitidine hydrochloride....................................................... 3708 Rotation, optical (2.2.7.) ............................................................ 26
Rapeseed oil, refined .............................................................. 3709 Rotavirus diarrhoea vaccine (inactivated), calf .................. 1078
Raw materials of biological origin for the production of Rotavirus vaccine (live, oral)................................................. 1033
cell-based and gene therapy medicinal products (5.2.12.).. 675 Rotigotine ................................................................................ 3748
Reagents (4.).............................................................................. 481 Round amomum fruit ............................................................ 1604
Reagents (4.1.1.)........................................................................ 481 Roxithromycin ........................................................................ 3750
Reagents, standard solutions, buffer solutions (4.1.) ........... 481 RRR-α-Tocopherol.................................................................. 4058
Recombinant DNA technology, products of......................... 888 RRR-α-Tocopheryl acetate..................................................... 4060
Recombinant vectors ............................................................... 779 RRR-α-Tocopheryl hydrogen succinate ............................... 4064
Recommendations on dissolution testing (5.17.1.) .............. 801 Rubber closures for containers for aqueous parenteral
Recommendations on methods for dosage forms testing preparations, for powders and for freeze-dried powders
(5.17.) ....................................................................................... 801 (3.2.9.) ...................................................................................... 460
Rectal capsules .......................................................................... 934 Rubella immunoglobulin, human ........................................ 2872
Rectal foams .............................................................................. 935 Rubella, measles and mumps vaccine (live) ........................ 1005
Rectal preparations................................................................... 933 Rubella, measles, mumps and varicella vaccine (live)........ 1006
Rectal preparations, semi-solid............................................... 935 Rubella vaccine (live) ............................................................. 1035
Rectal solutions and suspensions, powders and tablets for.. 933 Ruminant colibacillosis vaccine (inactivated), neonatal.... 1133
Rectal solutions, emulsions and suspensions........................ 934 Rupatadine fumarate .............................................................. 3752
Rectal tampons.......................................................................... 935 Rutoside trihydrate ................................................................. 3753
Red peony root........................................................................ 1572
Red poppy petals..................................................................... 1595 S
Reference standards (5.12.) ..................................................... 773 Saccharin.................................................................................. 3759
Refractive index (2.2.6.) ............................................................. 26 Saccharin sodium ................................................................... 3760
Regorafenib monohydrate ..................................................... 3710 Safety, viral (5.1.7.) ................................................................... 637
Relative density (2.2.5.).............................................................. 25 Safflower flower ...................................................................... 1606
Remifentanil hydrochloride .................................................. 3711 Safflower oil, refined............................................................... 3761
Repaglinide.............................................................................. 3714 Saffron for homoeopathic preparations............................... 1710
Reserpine ................................................................................. 3715 Sage leaf (Salvia officinalis) ................................................... 1607
Residual pertussis toxin (2.6.33.)............................................ 241 Sage leaf, three-lobed ............................................................. 1608
Residual solvents (5.4.) ............................................................ 717 Sage oil, Spanish...................................................................... 1629
Residual solvents, identification and control (2.4.24.) ......... 152 Sage tincture ............................................................................ 1609
Residue on evaporation of essential oils (2.8.9.)................... 306 Salbutamol ............................................................................... 3761
Residues, pesticide (2.8.13.)..................................................... 308 Salbutamol sulfate................................................................... 3764
Resistance to crushing of tablets (2.9.8.) ............................... 337 Salicylic acid ............................................................................ 3766
Resorcinol ................................................................................ 3716 Salmeterol xinafoate ............................................................... 3767
Respiratory syncytial virus vaccine (live), bovine .............. 1074 Salmon oil, farmed ................................................................. 3769
Restharrow root ...................................................................... 1596 Salmonella Enteritidis vaccine (inactivated) for chickens.. 1151
Rhatany root............................................................................ 1597 Salmonella Enteritidis vaccine (live, oral) for chickens ..... 1152
Rhatany tincture ..................................................................... 1598 Salmonella Typhimurium vaccine (inactivated) for
Rhinotracheitis vaccine (inactivated), bovine, infectious.. 1120 chickens ................................................................................. 1155
Rhinotracheitis vaccine (inactivated), viral, feline ............. 1113 Salmonella Typhimurium vaccine (live, oral) for
Rhinotracheitis vaccine (live), bovine, infectious............... 1121 chickens ................................................................................. 1156
Rhinotracheitis vaccine (live), infectious, turkey ............... 1162 Salmonids, infectious pancreatic necrosis vaccine (inactivated
Rhinotracheitis vaccine (live), viral, feline .......................... 1114 oil-adjuvanted, injectable) for ............................................. 1124
Rhubarb ................................................................................... 1598 Salvia miltiorrhiza root and rhizome................................... 1610
Ribavirin .................................................................................. 3717 Sanguisorba root..................................................................... 1611
Riboflavin................................................................................. 3718 Saponification value (2.5.6.) .................................................... 169
Riboflavin sodium phosphate ............................................... 3720 Saquinavir mesilate................................................................. 3771
Ribose in polysaccharide vaccines (2.5.31.) .......................... 177 Saw palmetto extract .............................................................. 1612
Ribwort plantain ..................................................................... 1599 Saw palmetto fruit .................................................................. 1615
Rice starch ............................................................................... 3721 Scanning electron microscopy (2.9.52.)................................. 414
Rifabutin .................................................................................. 3722 Schisandra fruit....................................................................... 1617
Rifampicin ............................................................................... 3724 Scopolamine ............................................................................ 2909
Rifamycin sodium................................................................... 3725 Scopolamine butylbromide ................................................... 2910
Rifaximin ................................................................................. 3726 Scopolamine hydrobromide .................................................. 2911
Rilmenidine dihydrogen phosphate ..................................... 3728 Selamectin for veterinary use................................................ 3773
Risedronate sodium 2.5-hydrate........................................... 3729 Selegiline hydrochloride ........................................................ 3775
Risperidone ............................................................................. 3730 Selenium disulfide .................................................................. 3776
Ritonavir .................................................................................. 3732 Selenium for homoeopathic preparations ........................... 1725
Rivastigmine............................................................................ 3736 Selfheal fruit-spike, common ................................................ 1401
Rivastigmine hydrogen tartrate ............................................ 3737 Semi-micro determination of water (2.5.12.)........................ 171
Rizatriptan benzoate .............................................................. 3739 Semi-solid ear preparations..................................................... 908
Rocuronium bromide............................................................. 3740 Semi-solid eye preparations .................................................... 910
Rolling ball (automatic) and falling ball viscometer methods Semi-solid intrauterine preparations ..................................... 914
(2.2.49.) ...................................................................................... 94 Semi-solid nasal preparations ................................................. 920
Roman chamomile flower...................................................... 1384 Semi-solid oromucosal preparations...................................... 921
Ropinirole hydrochloride ...................................................... 3742 Semi-solid preparations for cutaneous application .............. 935
Ropivacaine hydrochloride monohydrate ........................... 3744
Semi-solid preparations for oral use, veterinary .................. 942 Sodium cetostearyl sulfate..................................................... 3810
Semi-solid rectal preparations ................................................ 935 Sodium chloride...................................................................... 3812
Semi-solid vaginal preparations ............................................. 941 Sodium chromate (51Cr) sterile solution.............................. 1226
Senega root .............................................................................. 1618 Sodium citrate ......................................................................... 3813
Senna leaf................................................................................. 1620 Sodium cromoglicate ............................................................. 3813
Senna leaf dry extract, standardised .................................... 1621 Sodium cyclamate................................................................... 3814
Senna pods, Alexandrian....................................................... 1622 Sodium dihydrogen phosphate dihydrate ........................... 3816
Senna pods, Tinnevelly .......................................................... 1623 Sodium disulfite ...................................................................... 3829
Separation techniques, chromatographic (2.2.46.) ................. 80 Sodium ethyl parahydroxybenzoate..................................... 3816
Serine........................................................................................ 3777 Sodium fluoride ...................................................................... 3818
Serratula coronata herb.......................................................... 1624 Sodium fluoride (18F) injection ............................................. 1227
Sertaconazole nitrate .............................................................. 3778 Sodium fusidate ...................................................................... 3818
Sertraline hydrochloride........................................................ 3779 Sodium glycerophosphate, hydrated .................................... 3821
Sesame oil, refined.................................................................. 3781 Sodium hyaluronate ............................................................... 3821
Sets for the transfusion of blood and blood components Sodium hydrogen carbonate ................................................. 3824
(3.3.7.) ...................................................................................... 475 Sodium hydroxide .................................................................. 3824
Sevoflurane .............................................................................. 3783 Sodium iodide......................................................................... 3825
Shampoos .................................................................................. 916 Sodium iodide (123I) injection ............................................... 1228
Shear cell methods, powder flow properties by (2.9.49.)..... 411 Sodium iodide (123I) solution for radiolabelling ................. 1228
Shellac ..................................................................................... 3785 Sodium iodide (131I) capsules for diagnostic use ................ 1229
Shingles (herpes zoster) vaccine (live) ................................. 1036 Sodium iodide (131I) capsules for therapeutic use .............. 1230
SI (International System) units (1.) ............................................ 3 Sodium iodide (131I) solution ................................................ 1231
Sialic acid in polysaccharide vaccines (2.5.23.)..................... 174 Sodium iodide (131I) solution for radiolabelling ................. 1232
Siam benzoin........................................................................... 1341 Sodium iodohippurate (123I) injection ................................. 1233
Siam benzoin tincture ............................................................ 1342 Sodium iodohippurate (131I) injection ................................. 1234
Sieve test (2.9.12.) ..................................................................... 343 Sodium iodohippurate dihydrate for radiopharmaceutical
Sieves (2.1.4.)............................................................................... 16 preparations .......................................................................... 1234
Sieving, analytical, particle-size distribution estimation by Sodium lactate solution ......................................................... 3825
(2.9.38.) .................................................................................... 392 Sodium laurilsulfate ............................................................... 3827
Sildenafil citrate ...................................................................... 3786 Sodium lauroylsarcosinate for external use......................... 3828
Silica, colloidal anhydrous..................................................... 3787 Sodium metabisulfite ............................................................. 3829
Silica, colloidal hydrated........................................................ 3788 Sodium methyl parahydroxybenzoate ................................. 3830
Silica, dental type.................................................................... 3788 Sodium molybdate (99Mo) solution (fission) ...................... 1235
Silica, hydrophobic colloidal ................................................. 3789 Sodium molybdate dihydrate................................................ 3831
Silicate, aluminium magnesium............................................ 1799 Sodium nitrite ......................................................................... 3832
Silicate, aluminium sodium................................................... 1803 Sodium nitroprusside............................................................. 3832
Silicone elastomer for closures and tubing (3.1.9.)............... 436 Sodium perborate, hydrated.................................................. 3833
Silicone oil used as a lubricant (3.1.8.)................................... 436 Sodium pertechnetate (99mTc) injection (accelerator-
Silk suture, sterile, braided, in distributor for veterinary produced) .............................................................................. 1237
use........................................................................................... 1283 Sodium pertechnetate (99mTc) injection (fission) ............... 1238
Silver, colloidal, for external use........................................... 3790 Sodium pertechnetate (99mTc) injection (non-fission) ....... 1240
Silver nitrate ............................................................................ 3790 Sodium phenylbutyrate.......................................................... 3833
Simeticone ............................................................................... 3791 Sodium phosphate (32P) injection......................................... 1240
Simvastatin .............................................................................. 3792 Sodium picosulfate ................................................................. 3835
Single-dose preparations, uniformity of content (2.9.6.)..... 336 Sodium polystyrene sulfonate ............................................... 3836
Single-dose preparations, uniformity of mass (2.9.5.) ......... 335 Sodium propionate ................................................................. 3837
Sintered-glass filters (2.1.2.) ...................................................... 15 Sodium propyl parahydroxybenzoate .................................. 3838
Sitagliptin phosphate monohydrate ..................................... 3795 Sodium pyrophosphate decahydrate for radiopharmaceutical
Sitagliptin tablets .................................................................... 3796 preparations .......................................................................... 1241
Size-exclusion chromatography (2.2.30.)................................. 51 Sodium risedronate 2.5-hydrate ........................................... 3729
(S)-Lactic acid ......................................................................... 3051 Sodium salicylate .................................................................... 3839
Smallpox vaccine (live) .......................................................... 1037 Sodium selenite....................................................................... 3840
Sodium acetate ([1-11C]) injection........................................ 1225 Sodium selenite pentahydrate ............................................... 3840
Sodium acetate trihydrate...................................................... 3797 Sodium (S)-lactate solution................................................... 3826
Sodium alendronate trihydrate ............................................. 3798 Sodium starch glycolate (type A).......................................... 3841
Sodium alginate ...................................................................... 3799 Sodium starch glycolate (type B).......................................... 3842
Sodium aluminium silicate.................................................... 1803 Sodium starch glycolate (type C).......................................... 3843
Sodium amidotrizoate............................................................ 3800 Sodium stearate....................................................................... 3844
Sodium aminosalicylate dihydrate ....................................... 3801 Sodium stearyl fumarate........................................................ 3845
Sodium ascorbate ................................................................... 3802 Sodium sulfate, anhydrous .................................................... 3846
Sodium aurothiomalate ......................................................... 3804 Sodium sulfate decahydrate................................................... 3847
Sodium benzoate .................................................................... 3805 Sodium sulfite ......................................................................... 3847
Sodium bromide ..................................................................... 3806 Sodium sulfite heptahydrate.................................................. 3848
Sodium calcium edetate......................................................... 3807 Sodium tetrachloroaurate dihydrate for homoeopathic
Sodium calcium pentetate for radiopharmaceutical preparations .......................................................................... 1704
preparations .......................................................................... 1223 Sodium thiosulfate.................................................................. 3848
Sodium caprylate .................................................................... 3808 Sodium valproate.................................................................... 3849
Sodium carbonate................................................................... 3809 Soft capsules .............................................................................. 906
Sodium carbonate decahydrate............................................. 3809 Soft extracts ............................................................................... 867
Sodium carbonate monohydrate .......................................... 3810 Softening time determination of lipophilic suppositories
Sodium carboxymethylcellulose ........................................... 2093 (2.9.22.) .................................................................................... 363
Sodium carboxymethylcellulose, cross-linked.................... 2318 Solid dosage forms, dissolution test for (2.9.3.).................... 326
Sodium carboxymethylcellulose, low-substituted .............. 2094

Solid dosage forms, recommendations on dissolution testing St. John’s wort.......................................................................... 1631
of (5.17.1.)................................................................................ 801 St. John’s wort dry extract, quantified.................................. 1633
Solids by mercury porosimetry, porosity and pore-size Standard solutions for limit tests (4.1.2.)............................... 598
distribution of (2.9.32.).......................................................... 377 Standards, reference (5.12.) ..................................................... 773
Solids, density of (2.2.42.).......................................................... 76 Stannous chloride dihydrate.................................................. 3886
Solids, gas pycnometric density of (2.9.23.) .......................... 364 Stanozolol ................................................................................ 3887
Solids (porous) including powders, wettability of (2.9.45.).. 406 Staphysagria for homoeopathic preparations ..................... 1726
Solifenacin succinate .............................................................. 3850 Star anise.................................................................................. 1635
Solubility in alcohol of essential oils (2.8.10.)....................... 306 Star anise oil ............................................................................ 1636
Soluble tablets ........................................................................... 939 Starch glycolate (type A), sodium......................................... 3841
Solution calorimetry and microcalorimetry, characterisation Starch glycolate (type B), sodium ......................................... 3842
of crystalline solids by (2.2.61.) ............................................ 115 Starch glycolate (type C), sodium......................................... 3843
Solutions, emulsions and suspensions, oral .......................... 917 Starch, hydroxypropyl ............................................................ 3888
Solutions for haemodialysis................................................... 2798 Starch, hydroxypropyl, pregelatinised.................................. 3890
Solutions for haemodialysis, concentrated, water for Starch, maize ........................................................................... 3167
diluting................................................................................... 2797 Starch, pea ............................................................................... 3492
Solutions for haemofiltration and haemodiafiltration ....... 2803 Starch, potato .......................................................................... 3611
Solutions for organ preservation .......................................... 3852 Starch, pregelatinised ............................................................. 3891
Solutions for peritoneal dialysis............................................ 3515 Starch, rice ............................................................................... 3721
Solutions, suspensions, intrauterine....................................... 914 Starch, wheat ........................................................................... 4209
Solvents, residual (5.4.) ............................................................ 717 Starches, hydroxyethyl ........................................................... 3892
Solvents, residual, identification and control (2.4.24.)......... 152 Starflower (borage) oil, refined ............................................. 1992
Somatostatin............................................................................ 3853 Statistical analysis of results of biological assays and tests
Somatropin .............................................................................. 3854 (5.3.) ......................................................................................... 685
Somatropin concentrated solution ....................................... 3856 Stavudine ................................................................................. 3896
Somatropin for injection ....................................................... 3858 Steam sterilisation of aqueous preparations, application of the
Somatropin solution for injection ........................................ 3860 F0 concept (5.1.5.) ................................................................... 628
Sophora flower ........................................................................ 1626 Stearic acid............................................................................... 3898
Sophora flower-bud................................................................ 1628 Stearoyl macrogolglycerides .................................................. 3899
Sorbic acid ............................................................................... 3861 Stearyl alcohol ......................................................................... 3900
Sorbitan laurate....................................................................... 3862 Stem cells, human haematopoietic ....................................... 2857
Sorbitan oleate......................................................................... 3862 Stephania root, fourstamen ................................................... 1438
Sorbitan palmitate .................................................................. 3863 Sterile braided silk suture in distributor for veterinary
Sorbitan sesquioleate.............................................................. 3863 use........................................................................................... 1283
Sorbitan stearate ..................................................................... 3864 Sterile catgut............................................................................ 1269
Sorbitan trioleate .................................................................... 3865 Sterile catgut in distributor for veterinary use.................... 1281
Sorbitol..................................................................................... 3865 Sterile containers of plasticised poly(vinyl chloride) for human
Sorbitol, liquid (crystallising) ............................................... 3867 blood containing anticoagulant solution (3.3.6.) ............... 474
Sorbitol, liquid (non-crystallising) ....................................... 3867 Sterile linen thread in distributor for veterinary use ......... 1282
Sorbitol, liquid, partially dehydrated ................................... 3868 Sterile non-absorbable strands in distributor for veterinary
Sorption-desorption isotherms and water activity, use........................................................................................... 1283
determination of (water-solid interactions) (2.9.39.)......... 394 Sterile non-absorbable sutures .............................................. 1270
Sotalol hydrochloride............................................................. 3869 Sterile plastic containers for human blood and blood
Soya phospholipids for injection .......................................... 3870 components (3.3.4.)................................................................ 471
Soya-bean oil, hydrogenated ................................................. 3872 Sterile polyamide suture in distributor for veterinary use.. 1282
Soya-bean oil, refined............................................................. 3873 Sterile poly(ethylene terephthalate) suture in distributor for
Spanish sage oil ....................................................................... 1629 veterinary use........................................................................ 1283
Specific surface area by air permeability (2.9.14.) ................ 343 Sterile products, biological indicators and related microbial
Specific surface area by gas adsorption (2.9.26.) .................. 369 preparations used in the manufacture of (5.1.2.) ............... 622
Spectinomycin dihydrochloride pentahydrate.................... 3873 Sterile products, methods of preparation of (5.1.1.) ............ 619
Spectinomycin sulfate tetrahydrate for veterinary use ...... 3875 Sterile single-use plastic syringes (3.3.8.) .............................. 477
Spectrometry, atomic absorption (2.2.23.).............................. 37 Sterile synthetic absorbable braided sutures ....................... 1274
Spectrometry, atomic emission (2.2.22.) ................................. 36 Sterile synthetic absorbable monofilament sutures ............ 1275
Spectrometry, mass (2.2.43.) ..................................................... 77 Sterility (2.6.1.).......................................................................... 191
Spectrometry, nuclear magnetic resonance (2.2.33.) ............. 58 Sterility, guidelines for using the test for (5.1.9.).................. 639
Spectrometry, X-ray fluorescence (2.2.37.) ............................. 65 Sterols in fatty oils (2.4.23.) ..................................................... 150
Spectrophotometry, infrared absorption (2.2.24.) ................. 39 Sticks .......................................................................................... 937
Spectrophotometry, ultraviolet and visible absorption Sticks, intrauterine.................................................................... 914
(2.2.25.) ...................................................................................... 42 Sticks, nasal ............................................................................... 920
Spectroscopy, near-infrared (2.2.40.)....................................... 70 Stomata and stomatal index (2.8.3.) ....................................... 305
Spectroscopy, Raman (2.2.48.).................................................. 92 Stramonium leaf ..................................................................... 1638
SPF chicken flocks for the production and quality control of Stramonium, prepared ........................................................... 1640
vaccines (5.2.2.)....................................................................... 647 Strands, sterile non-absorbable, in distributor for veterinary
Spheroids and granules, friability of (2.9.41.) ....................... 400 use .......................................................................................... 1283
Spike lavender oil.................................................................... 1630 Streptokinase concentrated solution .................................... 3901
Spiramycin............................................................................... 3877 Streptomycin sulfate ............................................................... 3902
Spirapril hydrochloride monohydrate ................................. 3880 Strontium (89Sr) chloride injection....................................... 1242
Spironolactone ........................................................................ 3881 Strychnos ignatii for homoeopathic preparations.............. 1719
Spot-on preparations................................................................ 942 Subdivision of tablets ............................................................... 937
Sprays (liquid nasal) and drops (nasal).................................. 919 Sublingual sprays, oromucosal drops and oromucosal
Sprays, veterinary ..................................................................... 942 sprays........................................................................................ 920
Squalane................................................................................... 3883 Sublingual tablets and buccal tablets...................................... 922
Squalene................................................................................... 3886 Substances for pharmaceutical use......................................... 890
Substances for pharmaceutical use, control of impurities in Szechwan lovage rhizome ...................................................... 1642
(5.10.) ....................................................................................... 763
Substances of animal origin for the production of T
immunological veterinary medicinal products (5.2.5.) ..... 656 Table of physical characteristics of radionuclides mentioned in
Substitution of in vivo method(s) by in vitro method(s) for the the European Pharmacopoeia (5.7.)..................................... 745
quality control of vaccines (5.2.14.) ..................................... 679 Tablets ........................................................................................ 937
Sub-visible particles, particulate contamination (2.9.19.) ... 360 Tablets and capsules, disintegration of (2.9.1.) ..................... 323
Sucralfate ................................................................................. 3904 Tablets and powders for rectal solutions and suspensions .. 934
Sucralose .................................................................................. 3905 Tablets, buccal ........................................................................... 922
Sucrose ..................................................................................... 3906 Tablets, chewable ...................................................................... 939
Sucrose, liquid......................................................................... 3908 Tablets, coated ........................................................................... 938
Sucrose monopalmitate.......................................................... 3909 Tablets, dispersible.................................................................... 939
Sucrose stearate....................................................................... 3911 Tablets, effervescent.................................................................. 939
Sufentanil ................................................................................. 3912 Tablets for intrauterine solutions and suspensions .............. 914
Sufentanil citrate ..................................................................... 3913 Tablets for vaginal solutions and suspensions ...................... 941
Sugar spheres........................................................................... 3915 Tablets, gastro-resistant............................................................ 938
Sugars, lead in (2.4.10.) ............................................................ 142 Tablets, intrauterine.................................................................. 914
Sulbactam sodium .................................................................. 3915 Tablets, modified-release ......................................................... 939
Sulfacetamide sodium ............................................................ 3917 Tablets, orodispersible.............................................................. 939
Sulfadiazine ............................................................................. 3918 Tablets, resistance to crushing (2.9.8.) ................................... 337
Sulfadimethoxine.................................................................... 3920 Tablets, soluble .......................................................................... 939
Sulfadimethoxine sodium for veterinary use ...................... 3921 Tablets, subdivision of.............................................................. 937
Sulfadimidine .......................................................................... 3922 Tablets, sublingual .................................................................... 922
Sulfadoxine .............................................................................. 3924 Tablets, uncoated ...................................................................... 938
Sulfafurazole............................................................................ 3925 Tablets, uncoated, friability of (2.9.7.) ................................... 336
Sulfaguanidine ........................................................................ 3926 Tablets, vaginal.......................................................................... 941
Sulfamerazine.......................................................................... 3926 Tacalcitol monohydrate.......................................................... 3953
Sulfamethizole......................................................................... 3927 Tacrolimus monohydrate....................................................... 3954
Sulfamethoxazole.................................................................... 3928 Tadalafil.................................................................................... 3957
Sulfamethoxypyridazine for veterinary use......................... 3929 Talc ........................................................................................... 3959
Sulfanilamide........................................................................... 3930 Tamoxifen citrate .................................................................... 3961
Sulfasalazine ............................................................................ 3931 Tampons, ear ............................................................................. 909
Sulfated ash (2.4.14.) ................................................................ 142 Tampons, medicated ............................................................... 940
Sulfates (2.4.13.)........................................................................ 142 Tampons, rectal......................................................................... 935
Sulfathiazole ............................................................................ 3933 Tampons, vaginal, medicated .................................................. 941
Sulfinpyrazone......................................................................... 3934 Tamsulosin hydrochloride..................................................... 3963
Sulfobutylbetadex sodium ..................................................... 3935 Tannic acid .............................................................................. 3964
Sulfur dioxide (2.5.29.)............................................................. 177 Tannins in herbal drugs (2.8.14.)............................................ 310
Sulfur for external use............................................................ 3938 Tapentadol hydrochloride ..................................................... 3965
Sulfur for homoeopathic preparations................................. 1727 Tapped density and bulk density of powders (2.9.34.)......... 384
Sulfuric acid............................................................................. 3938 Tartaric acid............................................................................. 3966
Sulindac.................................................................................... 3939 Tea tree oil ............................................................................... 1643
Sulpiride................................................................................... 3940 Teat dips..................................................................................... 942
Sultamicillin ............................................................................ 3941 Teat sprays ................................................................................. 942
Sultamicillin tosilate dihydrate ............................................. 3944 Technetium (99mTc) bicisate injection .................................. 1243
Sumatra benzoin ..................................................................... 1341 Technetium (99mTc) colloidal rhenium sulfide injection ... 1244
Sumatra benzoin tincture ...................................................... 1343 Technetium (99mTc) colloidal sulfur injection ..................... 1244
Sumatriptan succinate............................................................ 3946 Technetium (99mTc) colloidal tin injection .......................... 1245
Sunflower oil, refined ............................................................. 3948 Technetium (99mTc) etifenin injection.................................. 1246
Supercritical fluid chromatography (2.2.45.) .......................... 80 Technetium (99mTc) exametazime injection ........................ 1247
Suppositories ............................................................................. 934 Technetium (99mTc) gluconate injection .............................. 1248
Suppositories and pessaries, disintegration of (2.9.2.) ......... 325 Technetium (99mTc) human albumin injection ................... 1249
Suppositories, lipophilic, softening time determination Technetium (99mTc) macrosalb injection ............................. 1251
(2.9.22.) .................................................................................... 363 Technetium (99mTc) mebrofenin injection ........................... 1252
Suspensions, solutions and emulsions, oral .......................... 917 Technetium (99mTc) medronate injection ............................ 1253
Suspensions, solutions, intrauterine....................................... 914 Technetium (99mTc) mertiatide injection ............................. 1254
Sutures for human use : introduction................................... 1269 Technetium (99mTc) microspheres injection ........................ 1255
Sutures, sterile non-absorbable ............................................. 1270 Technetium (99mTc) oxidronate injection ............................ 1256
Sutures, sterile synthetic absorbable braided ..................... 1274 Technetium (99mTc) pentetate injection ............................... 1257
Sutures, sterile synthetic absorbable monofilament .......... 1275 Technetium (99mTc) sestamibi injection ............................... 1258
Suxamethonium chloride ...................................................... 3948 Technetium (99mTc) succimer injection................................ 1259
Suxibuzone .............................................................................. 3949 Technetium (99mTc) tin pyrophosphate injection ............... 1260
Sweet fennel............................................................................. 1434 Teicoplanin .............................................................................. 3967
Sweet orange oil ...................................................................... 1641 Telmisartan.............................................................................. 3970
Swelling index (2.8.4.) .............................................................. 306 Temazepam.............................................................................. 3972
Swine erysipelas vaccine (inactivated) ................................. 1158 Temozolomide......................................................................... 3973
Swine-fever vaccine (live, prepared in cell cultures), Tenosynovitis vaccine (live), viral, avian ............................. 1069
classical .................................................................................. 1159 Tenoxicam ............................................................................... 3974
Symbols and abbreviations (1.)................................................... 3 Terazosin hydrochloride dihydrate ...................................... 3976
Synthetic absorbable braided sutures, sterile ...................... 1274 Terbinafine hydrochloride ..................................................... 3978
Synthetic absorbable monofilament sutures, sterile ........... 1275 Terbutaline sulfate .................................................................. 3979
Syringes, plastic, sterile single-use (3.3.8.) ............................ 477 Terconazole.............................................................................. 3980
Syrups......................................................................................... 918

Terfenadine.............................................................................. 3982 Tetra-O-acetyl-mannose triflate for radiopharmaceutical

Teriparatide ............................................................................. 3983 preparations .......................................................................... 1261
Terlipressin .............................................................................. 3986 Tetrazepam .............................................................................. 4003
Terminology used in monographs on biological products Tetryzoline hydrochloride ..................................................... 4004
(5.2.1.) ...................................................................................... 647 Thallous (201Tl) chloride injection ........................................ 1262
Terpin monohydrate............................................................... 3988 Theobromine........................................................................... 4005
Test for anticomplementary activity of immunoglobulin Theophylline ........................................................................... 4005
(2.6.17.) .................................................................................... 216 Theophylline monohydrate ................................................... 4007
Test for anti-D antibodies in human immunoglobulin Theophylline-ethylenediamine ............................................. 4008
(2.6.26.) .................................................................................... 230 Theophylline-ethylenediamine hydrate ............................... 4009
Test for aristolochic acids in herbal drugs (2.8.21) .............. 314 Thermal analysis (2.2.34.).......................................................... 61
Test for extractable volume of parenteral preparations Thermogravimetry (2.2.34.)...................................................... 61
(2.9.17.) .................................................................................... 347 Thiamazole .............................................................................. 4011
Test for Fc function of immunoglobulin (2.7.9.).................. 279 Thiamine hydrochloride ........................................................ 4012
Test for methanol and 2-propanol (2.9.11.) .......................... 342 Thiamine nitrate ..................................................................... 4014
Test for neurovirulence of live virus vaccines (2.6.18.)........ 218 Thiamphenicol ........................................................................ 4015
Test for specified micro-organisms (microbiological Thin-layer chromatography (2.2.27.) ....................................... 47
examination of non-sterile products) (2.6.13.) ................... 205 Thiocolchicoside crystallised from ethanol ........................ 4016
Testosterone............................................................................. 3989 Thiocolchicoside hydrate....................................................... 4018
Testosterone decanoate .......................................................... 3991 Thioctic acid............................................................................ 4020
Testosterone enantate ............................................................. 3992 Thiomersal............................................................................... 4021
Testosterone isocaproate ........................................................ 3994 Thiopental sodium and sodium carbonate ......................... 4022
Testosterone propionate......................................................... 3995 Thioridazine ............................................................................ 4024
Tests for extraneous agents in viral vaccines for human use Thioridazine hydrochloride .................................................. 4025
(2.6.16.) .................................................................................... 214 Thomson kudzuvine root ...................................................... 1644
Tests for specified micro-organisms (microbiological Three-lobed sage leaf ............................................................. 1608
examination of live biotherapeutic products) (2.6.38.)...... 255 Threonine ................................................................................ 4027
Tetanus and diphtheria toxins and toxoids, flocculation value Thyme ...................................................................................... 1646
(Lf) of, (Ramon assay) (2.7.27.)............................................ 295 Thyme oil, thymol type.......................................................... 1648
Tetanus and diphtheria vaccine (adsorbed) .......................... 952 Thyme, wild............................................................................. 1669
Tetanus and diphtheria vaccine (adsorbed, reduced antigen(s) Thymol..................................................................................... 4028
content).................................................................................... 953 Thymol type thyme oil........................................................... 1648
Tetanus antitoxin for human use .......................................... 1173 Tiabendazole ........................................................................... 4029
Tetanus antitoxin for veterinary use..................................... 1177 Tiamulin for veterinary use................................................... 4030
Tetanus, diphtheria and hepatitis B (rDNA) vaccine Tiamulin hydrogen fumarate for veterinary use................. 4032
(adsorbed) ............................................................................... 954 Tianeptine sodium.................................................................. 4035
Tetanus, diphtheria and pertussis (acellular, component) Tiapride hydrochloride .......................................................... 4036
vaccine (adsorbed) ................................................................. 955 Tiaprofenic acid ...................................................................... 4037
Tetanus, diphtheria and pertussis (acellular, component) Tibolone................................................................................... 4039
vaccine (adsorbed, reduced antigen(s) content)................. 956 Ticarcillin sodium .................................................................. 4040
Tetanus, diphtheria and pertussis (whole cell) vaccine Tick-borne encephalitis vaccine (inactivated) .................... 1043
(adsorbed) ............................................................................... 958 Ticlopidine hydrochloride ..................................................... 4041
Tetanus, diphtheria and poliomyelitis (inactivated) vaccine Tigecycline............................................................................... 4043
(adsorbed, reduced antigen(s) content)............................... 959 Tilidine hydrochloride hemihydrate .................................... 4045
Tetanus, diphtheria, pertussis (acellular, component) and Timolol maleate ...................................................................... 4046
haemophilus type b conjugate vaccine (adsorbed) ............ 961 Tinctures .................................................................................... 867
Tetanus, diphtheria, pertussis (acellular, component) and Tinidazole ................................................................................ 4048
hepatitis B (rDNA) vaccine (adsorbed) ............................... 963 Tinnevelly senna pods............................................................ 1623
Tetanus, diphtheria, pertussis (acellular, component) and Tinzaparin sodium ................................................................. 4049
poliomyelitis (inactivated) vaccine (adsorbed)................... 964 Tioconazole ............................................................................. 4050
Tetanus, diphtheria, pertussis (acellular, component) and Tiotropium bromide monohydrate ...................................... 4051
poliomyelitis (inactivated) vaccine (adsorbed, reduced Titanium dioxide .................................................................... 4052
antigen(s) content) ................................................................. 966 Titration, amperometric (2.2.19.) ............................................. 35
Tetanus, diphtheria, pertussis (acellular, component), Titration, potentiometric (2.2.20.)............................................ 35
hepatitis B (rDNA), poliomyelitis (inactivated) and Titration, voltametric (2.2.65.)................................................ 119
haemophilus type b conjugate vaccine (adsorbed) ............ 968 Titrations, complexometric (2.5.11.)...................................... 170
Tetanus, diphtheria, pertussis (acellular, component), Tizanidine hydrochloride ...................................................... 4053
poliomyelitis (inactivated) and haemophilus type b conjugate Tobramycin.............................................................................. 4055
vaccine (adsorbed) ................................................................. 970 Tocopherol, all-rac-α-............................................................. 4057
Tetanus, diphtheria, pertussis (whole cell) and poliomyelitis Tocopherol, RRR-α-................................................................ 4058
(inactivated) vaccine (adsorbed) .......................................... 973 Tocopheryl acetate, all-rac-α- ............................................... 4059
Tetanus, diphtheria, pertussis (whole cell), poliomyelitis α-Tocopheryl acetate concentrate (powder form).............. 4062
(inactivated) and haemophilus type b conjugate vaccine Tocopheryl acetate, RRR-α-................................................... 4060
(adsorbed) ............................................................................... 974 Tocopheryl hydrogen succinate, DL-α- ................................ 4062
Tetanus immunoglobulin, human ........................................ 2873 Tocopheryl hydrogen succinate, RRR-α- ............................. 4064
Tetanus vaccine (adsorbed) ................................................... 1042 Tolbutamide............................................................................. 4066
Tetanus vaccine (adsorbed), assay of (2.7.8.) ........................ 275 Tolfenamic acid ....................................................................... 4067
Tetanus vaccine for veterinary use ....................................... 1161 Tolnaftate ................................................................................. 4068
Tetracaine ................................................................................ 3997 Tolterodine tartrate................................................................. 4070
Tetracaine hydrochloride....................................................... 3998 Tolu balsam ............................................................................. 1649
Tetracosactide.......................................................................... 3999 Toluenesulfonate (methyl, ethyl and isopropyl) in active
Tetracycline ............................................................................. 4000 substances (2.5.40.)................................................................. 185
Tetracycline hydrochloride.................................................... 4001 Topiramate............................................................................... 4071
Torasemide .............................................................................. 4073 Tylosin for veterinary use ...................................................... 4122

Tormentil ................................................................................. 1650 Tylosin phosphate bulk solution for veterinary use ........... 4127
Tormentil tincture .................................................................. 1650 Tylosin phosphate for veterinary use ................................... 4131
Tosylchloramide sodium ....................................................... 4074 Tylosin tartrate for veterinary use ........................................ 4136
Total ash (2.4.16.)...................................................................... 143 Typhae pollen.......................................................................... 1656
Total cholesterol in oils rich in omega-3 acids (2.4.32.) ...... 163 Typhoid polysaccharide and hepatitis A (inactivated,
Total organic carbon in water for pharmaceutical use adsorbed) vaccine ................................................................... 982
(2.2.44.) ...................................................................................... 79 Typhoid polysaccharide vaccine ........................................... 1044
Total protein (2.5.33.)............................................................... 178 Typhoid vaccine ...................................................................... 1046
Traditional Chinese medicine, names of herbal drugs used in Typhoid vaccine (live, oral, strain Ty 21a) .......................... 1046
(5.22.) ....................................................................................... 839 Tyrosine ................................................................................... 4140
Tragacanth ............................................................................... 1651 Tyrothricin............................................................................... 4142
Tramadol hydrochloride ........................................................ 4074
Tramazoline hydrochloride monohydrate........................... 4076 U
Trandolapril............................................................................. 4077 Ubidecarenone ........................................................................ 4147
Tranexamic acid...................................................................... 4078 Udder-washes............................................................................ 942
Transdermal patches ................................................................ 925 Ultraviolet and visible absorption spectrophotometry
Transdermal patches, dissolution test for (2.9.4.)................. 333 (2.2.25.) ...................................................................................... 42
Trapidil..................................................................................... 4079 Ultraviolet ray lamps for analytical purposes (2.1.3.) ............ 15
Trehalose dihydrate ................................................................ 4080 Uncaria stem with hooks ....................................................... 1657
Tretinoin .................................................................................. 4082 Uncoated tablets ....................................................................... 938
Triacetin ................................................................................... 4083 Undecylenic acid..................................................................... 4148
Triamcinolone ......................................................................... 4083 Uniformity of content of single-dose preparations (2.9.6.).. 336
Triamcinolone acetonide ....................................................... 4085 Uniformity of dosage units (2.9.40.) ...................................... 398
Triamcinolone hexacetonide ................................................. 4086 Uniformity of dosage units, demonstration using large sample
Triamterene ............................................................................. 4088 sizes (2.9.47.) ........................................................................... 409
Tribenoside.............................................................................. 4089 Uniformity of mass of delivered doses from multidose
Tributyl acetylcitrate............................................................... 4090 containers (2.9.27.) ................................................................. 372
Trichloroacetic acid ................................................................ 4092 Uniformity of mass of single-dose preparations (2.9.5.) ..... 335
Triclabendazole for veterinary use ....................................... 4093 Units of the International System (SI) used in the
Triethanolamine...................................................................... 4106 Pharmacopoeia and equivalence with other units (1.) .......... 3
Triethyl citrate......................................................................... 4094 Unsaponifiable matter (2.5.7.)................................................. 169
Trifluoperazine hydrochloride .............................................. 4095 Urea .......................................................................................... 4149
Triflusal .................................................................................... 4095 Urofollitropin .......................................................................... 4149
Triglycerides, medium-chain ................................................ 4096 Urokinase................................................................................. 4151
Triglycerides, omega-3-acid .................................................. 3423 Uronic acids in polysaccharide vaccines (2.5.22.) ................ 174
Triglycerol diisostearate ......................................................... 4097 Ursodeoxycholic acid ............................................................ 4152
Trihexyphenidyl hydrochloride ............................................ 4098 Urtica dioica for homoeopathic preparations..................... 1728
Trimebutine maleate .............................................................. 4099
Trimeprazine hemitartrate .................................................... 1782
V
Trimetazidine dihydrochloride ............................................. 4100
Trimethadione......................................................................... 4101 Vaccine component assay by immunonephelometry
Trimethoprim.......................................................................... 4102 (2.7.35.) .................................................................................... 301
Trimipramine maleate............................................................ 4104 Vaccines, adsorbed, aluminium in (2.5.13.) .......................... 171
Tri-n-butyl phosphate ............................................................ 4091 Vaccines, adsorbed, calcium in (2.5.14.)................................ 172
Tritiated (3H) water injection ................................................ 1263 Vaccines and immunosera, phenol in (2.5.15.)..................... 172
Trolamine................................................................................. 4106 Vaccines and immunosera, veterinary, evaluation of efficacy
Trometamol ............................................................................. 4107 of (5.2.7.).................................................................................. 661
Tropicamide............................................................................. 4108 Vaccines and immunosera, veterinary, evaluation of safety
Tropisetron hydrochloride..................................................... 4110 (5.2.6.) ...................................................................................... 658
Trospium chloride .................................................................. 4111 Vaccines for human use ........................................................... 893
Troxerutin................................................................................ 4112 Vaccines for human use, cell substrates for the production of
Trypsin ..................................................................................... 4114 (5.2.3.) ...................................................................................... 650
Tryptophan .............................................................................. 4115 Vaccines for human use, conjugated polysaccharide, carrier
TSE, animal, minimising the risk of transmitting via human proteins for the production of (5.2.11.) ............................... 674
and veterinary medicinal products (5.2.8.) ......................... 661 Vaccines for human use, viral, tests for extraneous agents in
TSE, animal, products with risk of transmitting agents of.. 884 (2.6.16.) .................................................................................... 214
Tuberculin for human use, old.............................................. 4117 Vaccines for veterinary use...................................................... 896
Tuberculin purified protein derivative, avian ..................... 4119 Vaccines for veterinary use, inactivated, healthy chicken flocks
Tuberculin purified protein derivative, bovine ................... 4120 for the production of (5.2.13.) .............................................. 679
Tuberculin purified protein derivative for human use....... 4120 Vaccines, polysaccharide, hexosamines in (2.5.20.) ............. 173
Tuberculosis (BCG) vaccine, freeze-dried............................. 949 Vaccines, polysaccharide, methylpentoses in (2.5.21.)......... 173
Tubes for comparative tests (2.1.5.).......................................... 17 Vaccines, polysaccharide, nucleic acids in (2.5.17.) ............. 172
Tubing and closures, silicone elastomer for (3.1.9.) ............. 436 Vaccines, polysaccharide, O-acetyl in (2.5.19.) ..................... 173
Tubing and containers for total parenteral nutrition Vaccines, polysaccharide, phosphorus in (2.5.18.) ............... 172
preparations, poly(ethylene - vinyl acetate) for (3.1.7.)..... 434 Vaccines, polysaccharide, protein in (2.5.16.)....................... 172
Tubing used in sets for the transfusion of blood and blood Vaccines, polysaccharide, ribose in (2.5.31.)......................... 177
components, materials based on plasticised poly(vinyl Vaccines, polysaccharide, sialic acid in (2.5.23.) .................. 174
chloride) for (3.3.3.) ............................................................... 468 Vaccines, polysaccharide, uronic acids in (2.5.22.) .............. 174
Turkey infectious rhinotracheitis vaccine (live) ................. 1162 Vaccines, SPF chicken flocks for the production and quality
Turmeric, Javanese.................................................................. 1652 control of (5.2.2.) ................................................................... 647
Turmeric rhizome................................................................... 1653 Vaccines, substitution of in vivo method(s) by in vitro
Turpentine oil.......................................................................... 1655 method(s) for the quality control of (5.2.14.) ..................... 679

Vaccines, veterinary, cell cultures for the production of Viral rhinotracheitis vaccine (live), feline ........................... 1114
(5.2.4.) ...................................................................................... 654 Viral safety (5.1.7.).................................................................... 637
Vaccines, viral live, test for neurovirulence (2.6.18.) ........... 218 Viral tenosynovitis vaccine (live), avian .............................. 1069
Vaginal capsules ........................................................................ 941 Viral vaccines for human use, tests for extraneous agents in
Vaginal foams............................................................................ 941 (2.6.16.) .................................................................................... 214
Vaginal preparations ................................................................ 940 Viscometer method, capillary (2.2.9.)...................................... 27
Vaginal preparations, semi-solid ............................................ 941 Viscometer methods, falling ball and automatic rolling ball
Vaginal solutions and suspensions, tablets for...................... 941 (2.2.49.) ...................................................................................... 94
Vaginal solutions, emulsions and suspensions...................... 941 Viscose wadding, absorbent .................................................. 4189
Vaginal tablets ........................................................................... 941 Viscosity - rotating viscometer method (2.2.10.) ................... 28
Vaginal tampons, medicated ................................................... 941 Viscosity (2.2.8.).......................................................................... 27
Valaciclovir hydrochloride .................................................... 4157 Visible and ultraviolet absorption spectrophotometry
Valaciclovir hydrochloride hydrate ...................................... 4160 (2.2.25.) ...................................................................................... 42
Valerian dry aqueous extract ............................................... 1659 Visible particles, particulate contamination (2.9.20.) .......... 362
Valerian dry hydroalcoholic extract ..................................... 1660 Vitamin A ................................................................................ 4191
Valerian root............................................................................ 1660 Vitamin A concentrate (oily form), synthetic ..................... 4192
Valerian root, cut .................................................................... 1662 Vitamin A concentrate (powder form), synthetic .............. 4193
Valerian tincture ..................................................................... 1664 Vitamin A concentrate (solubilisate/emulsion), synthetic.. 4194
Validation of nucleic acid amplification techniques for the Voltametric titration (2.2.65.) ................................................. 119
detection of B19 virus (B19V) DNA in plasma pools : Volumetric analysis (4.2.) ........................................................ 609
guidelines................................................................................. 219 Volumetric solutions (4.2.2.) ................................................... 609
Validation of nucleic acid amplification techniques for the Volumetric solutions, primary standards for (4.2.1.)........... 609
detection of hepatitis C virus (HCV) RNA in plasma pools : von Willebrand factor, human.............................................. 2875
guidelines................................................................................. 219 von Willebrand factor, human, assay of (2.7.21.) ................. 290
Valine ....................................................................................... 4162 Voriconazole............................................................................ 4196
Valnemulin hydrochloride for veterinary use .................... 4164
Valproate, sodium................................................................... 3849 W
Valproic acid............................................................................ 4165 Warfarin sodium..................................................................... 4201
Valsartan .................................................................................. 4167 Warfarin sodium clathrate..................................................... 4202
Vancomycin hydrochloride ................................................... 4168 Washes, nasal............................................................................. 920
Vanillin..................................................................................... 4172 Water (15O) injection .............................................................. 1264
Vapour, preparations to be converted into............................ 928 Water activity and sorption-desorption isotherms,
Vardenafil hydrochloride trihydrate..................................... 4172 determination of (water-solid interactions) (2.9.39.)......... 394
Varicella immunoglobulin for intravenous administration, Water, determination by distillation (2.2.13.) ......................... 31
human .................................................................................... 2875 Water for diluting concentrated haemodialysis solutions.. 2797
Varicella immunoglobulin, human ...................................... 2875 Water for injections ................................................................ 4203
Varicella, measles, mumps and rubella vaccine (live)........ 1006 Water for pharmaceutical use, total organic carbon in
Varicella vaccine (live) ........................................................... 1048 (2.2.44.) ...................................................................................... 79
Vectors for human use, adeno-associated-virus ................... 788 Water for preparation of extracts.......................................... 4206
Vectors for human use, adenovirus ........................................ 782 Water in essential oils (2.8.5.) ................................................. 306
Vectors for human use, plasmid ............................................. 780 Water in gases (2.5.28.) ............................................................ 176
Vectors for human use, plasmid, bacterial cells used for the Water : micro determination (2.5.32.) .................................... 178
manufacture of........................................................................ 781 Water, purified ........................................................................ 4207
Vectors for human use, poxvirus ............................................ 784 Water : semi-micro determination (2.5.12.) .......................... 171
Vectors for human use, retroviridae-derived ........................ 786 Water-solid interactions : determination of sorption-
Vecuronium bromide ............................................................. 4173 desorption isotherms and of water activity (2.9.39.) ......... 394
Vedaprofen for veterinary use............................................... 4175 Wettability of porous solids including powders (2.9.45.) .... 406
Vegetable fatty oils .................................................................... 901 Wheat starch............................................................................ 4209
Venlafaxine hydrochloride .................................................... 4176 Wheat-germ oil, refined......................................................... 4210
Verapamil hydrochloride ....................................................... 4178 Wheat-germ oil, virgin........................................................... 4210
Verbena herb ........................................................................... 1665 White beeswax ........................................................................ 1931
Veterinary liquid preparations for cutaneous application... 941 White horehound ................................................................... 1667
Veterinary medicinal products, immunological, substances of White peony root.................................................................... 1573
animal origin for the production of (5.2.5.)........................ 656 White soft paraffin.................................................................. 3485
Veterinary semi-solid preparations for oral use ................... 942 Wild pansy (flowering aerial parts)...................................... 1668
Veterinary vaccines and immunosera, evaluation of efficacy of Wild thyme.............................................................................. 1669
(5.2.7.) ...................................................................................... 661 Willow bark ............................................................................. 1671
Viability, nucleated cell count and (2.7.29.) .......................... 297 Willow bark dry extract ......................................................... 1672
Vibriosis (cold-water) vaccine (inactivated) for Wool alcohols .......................................................................... 4210
salmonids............................................................................... 1163 Wool fat.................................................................................... 4211
Vibriosis vaccine (inactivated) for salmonids ..................... 1164 Wool fat, hydrogenated.......................................................... 4215
VICH (5.8.)................................................................................ 755 Wool fat, hydrous.................................................................... 4216
Vigabatrin ................................................................................ 4180 Wormwood.............................................................................. 1673
Vinblastine sulfate .................................................................. 4181
Vincamine................................................................................ 4182
X
Vincristine sulfate................................................................... 4183
Vindesine sulfate..................................................................... 4185 Xanthan gum........................................................................... 4221
Vinorelbine tartrate ................................................................ 4186 Xenon (133Xe) injection .......................................................... 1264
Vinpocetine ............................................................................. 4188 X-ray fluorescence spectrometry (2.2.37.)............................... 65
Viper venom antiserum, European ...................................... 1174 X-ray powder diffraction (XRPD), characterisation of
Viral diarrhoea vaccine (inactivated), bovine ..................... 1075 crystalline and partially crystalline solids by (2.9.33.)....... 379
Viral hepatitis type I vaccine (live), duck ............................ 1099 Xylazine hydrochloride for veterinary use .......................... 4222
Viral rhinotracheitis vaccine (inactivated), feline .............. 1113 Xylitol ....................................................................................... 4223
Xylometazoline hydrochloride.............................................. 4225 Zinc acetate dihydrate ............................................................ 4238

Xylose ....................................................................................... 4226 Zinc acexamate ....................................................................... 4239
Zinc chloride ........................................................................... 4241
Y Zinc gluconate......................................................................... 4241
Yarrow ...................................................................................... 1674 Zinc oxide ................................................................................ 4242
Yeasticidal, bactericidal or fungicidal activity of antiseptic Zinc stearate ............................................................................ 4242
medicinal products, determination of (5.1.11.) .................. 643 Zinc sulfate heptahydrate ...................................................... 4243
Yellow beeswax........................................................................ 1932 Zinc sulfate hexahydrate ........................................................ 4244
Yellow fever vaccine (live) ..................................................... 1049 Zinc sulfate monohydrate...................................................... 4244
Yellow soft paraffin................................................................. 3486 Zinc undecylenate .................................................................. 4244
Yersiniosis vaccine (inactivated) for salmonids .................. 1102 Ziprasidone hydrochloride monohydrate............................ 4245
Yohimbine hydrochloride ...................................................... 4231 Ziprasidone mesilate trihydrate ............................................ 4247
Yttrium (90Y) chloride solution for radiolabelling.............. 1265 Zoledronic acid monohydrate............................................... 4249
Zolmitriptan ............................................................................ 4251
Zolpidem tartrate.................................................................... 4252
Z
Zopiclone ................................................................................. 4254
Zanamivir hydrate .................................................................. 4235 Zoster (shingles) vaccine (live), herpes................................ 1036
Zanthoxylum bungeanum pericarp...................................... 1675 Zuclopenthixol decanoate...................................................... 4255
Zidovudine .............................................................................. 4236

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EUROPEAN PHARMACOPOEIA 10.

1. General notices......................................................................... 3 2.2.66. Detection and measurement of radioactivity ........... 119

4260 See the information section on general monographs (cover pages)

5.19. Extemporaneous preparation of radiopharmaceuti- β-Acetyldigoxin....................................................................... 1750

4262 See the information section on general monographs (cover pages)

Alprostadil ............................................................................... 1791 Angelica archangelica root .................................................... 1309

4264 See the information section on general monographs (cover pages)

Betacarotene ............................................................................ 1959 Blood containing anticoagulant solution, human, sterile

Calcitriol .................................................................................. 2043 Captopril .................................................................................. 2075

4266 See the information section on general monographs (cover pages)

Celiprolol hydrochloride ....................................................... 2142 Chlorphenamine maleate ...................................................... 2187

Cloﬁbrate ................................................................................. 2259 Colistin sulfate ........................................................................ 2309

4268 See the information section on general monographs (cover pages)

Contamination, microbial : microbial enumeration tests Cytarabine ............................................................................... 2332

Diacerein.................................................................................. 2384 Diphtheria, tetanus, pertussis (acellular, component) and

4270 See the information section on general monographs (cover pages)

Ethionamide ............................................................................ 2580 F

4272 See the information section on general monographs (cover pages)

FET (18F) injection.................................................................. 1201 Folinate hydrate, calcium....................................................... 2049

Gases, water in (2.5.28.)........................................................... 176 Granisetron hydrochloride.................................................... 2787

4274 See the information section on general monographs (cover pages)

Heavy bismuth subnitrate...................................................... 1985 Histamine (2.6.10.) ................................................................... 200

Human C1-esterase inhibitor................................................ 2837 Hydrous wool fat .................................................................... 4216

4276 See the information section on general monographs (cover pages)

4278 See the information section on general monographs (cover pages)

Lithium citrate ........................................................................ 3105 Magnesium glycerophosphate............................................... 3158

Mebendazole ........................................................................... 3180 Methanesulfonic acid, methyl, ethyl and isopropyl

4280 See the information section on general monographs (cover pages)

Nimodipine ............................................................................. 3369 Oils, fatty, identiﬁcation by thin-layer chromatography

4282 See the information section on general monographs (cover pages)

4284 See the information section on general monographs (cover pages)

4286 See the information section on general monographs (cover pages)

Raltegravir tablets ................................................................... 3704 Roselle ...................................................................................... 1600

4288 See the information section on general monographs (cover pages)

4290 See the information section on general monographs (cover pages)

Terfenadine.............................................................................. 3982 Tetra-O-acetyl-mannose triﬂate for radiopharmaceutical

Torasemide .............................................................................. 4073 Tylosin for veterinary use ...................................................... 4122

4292 See the information section on general monographs (cover pages)

Xylometazoline hydrochloride.............................................. 4225 Zinc acetate dihydrate ............................................................ 4238

4294 See the information section on general monographs (cover pages)

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