4.1.2. Standard solutions for limit tests EUROPEAN PHARMACOPOEIA 5.

Zirconyl nitrate. A basic salt corresponding approximately Antimony standard solution (100 ppm Sb). 5000401.
to the formula ZrO(NO3)2,2H2O. 1097200. [14985-18-3]. Dissolve antimony potassium tartrate R equivalent to
A white powder or crystals, hygroscopic, soluble in water. 0.274 g of C4H4KO7 Sb,1/2H2O in 500 ml of 1M hydrochloric
The aqueous solution is a clear or at most slightly opalescent acid and dilute the clear solution to 1000 ml with water R.
liquid.
Antimony standard solution (1 ppm Sb). 5000400.
Storage : in an airtight container.
Dissolve antimony potassium tartrate R equivalent to
Zirconyl nitrate solution. 1097201. 0.274 g of C4H4KO7Sb,1/2H2O in 20 ml of hydrochloric
acid R1 and dilute the clear solution to 100.0 ml with
A 1 g/l solution in a mixture of 40 ml of water R and water R. To 10.0 ml of this solution add 200 ml of
60 ml of hydrochloric acid R. hydrochloric acid R1 and dilute to 1000.0 ml with water R.
To 100.0 ml of this solution add 300 ml of hydrochloric
acid R1 and dilute to 1000.0 ml with water R. Prepare the
dilute solutions immediately before use.
01/2005:40102
Arsenic standard solution (10 ppm As). 5000500.
Immediately before use, dilute with water R to 100 times
4.1.2. STANDARD SOLUTIONS FOR its volume a solution prepared by dissolving arsenious
LIMIT TESTS trioxide R equivalent to 0.330 g of As2O3 in 5 ml of dilute
sodium hydroxide solution R and diluting to 250.0 ml with
Acetaldehyde standard solution (100 ppm C2H4O). water R.
5000100.
Dissolve 1.0 g of acetaldehyde R in 2-propanol R and dilute Arsenic standard solution (1 ppm As). 5000501.
to 100.0 ml with the same solvent. Dilute 5.0 ml of the Immediately before use, dilute arsenic standard solution
solution to 500.0 ml with 2-propanol R. Prepare immediately (10 ppm As) R to 10 times its volume with water R.
before use.
Arsenic standard solution (0.1 ppm As). 5000502.
Acetaldehyde standard solution (100 ppm C2H4O) R1. Immediately before use, dilute arsenic standard solution
5000101. (1 ppm As) R to 10 times its volume with water R.
Dissolve 1.0 g of acetaldehyde R in water R and dilute to Barium standard solution (50 ppm Ba). 5000600.
100.0 ml with the same solvent. Dilute 5.0 ml of the solution
to 500.0 ml with water R. Prepare immediately before use. Immediately before use, dilute with distilled water R to
20 times its volume a solution in distilled water R containing
Aluminium standard solution (200 ppm Al). 5000200. barium chloride R equivalent to 0.178 g of BaCl2,2H2O in
100.0 ml.
Dissolve in water R a quantity of aluminium potassium
sulphate R equivalent to 0.352 g of AlK(SO4)2,12H2O. Add Bismuth standard solution (100 ppm Bi). 5005300.
10 ml of dilute sulphuric acid R and dilute to 100.0 ml with Dissolve bismuth R equivalent to 0.500 g of Bi in 50 ml of
water R. nitric acid R and dilute to 500.0 ml with water R. Dilute
the solution to 10 times its volume with dilute nitric acid R
Aluminium standard solution (100 ppm Al). 5000203.
immediately before use.
Immediately before use, dilute with water R to 10 times
its volume a solution containing 8.947 g of aluminium Cadmium standard solution (0.1 per cent Cd). 5000700.
chloride R in 1000.0 ml of water R. Dissolve cadmium R equivalent to 0.100 g of Cd in the
smallest necessary amount of a mixture of equal volumes of
Aluminium standard solution (10 ppm Al). 5000201. hydrochloric acid R and water R and dilute to 100.0 ml with
Immediately before use, dilute with water R to 100 times a 1 per cent V/V solution of hydrochloric acid R.
its volume in a solution containing aluminium nitrate R
equivalent to 1.39 g of Al(NO3)3,9H2O in 100.0 ml. Cadmium standard solution (10 ppm Cd) . 5000701.
Immediately before use, dilute cadmium standard solution
Aluminium standard solution (2 ppm Al). 5000202. (0.1 per cent Cd) R to 100 times its volume with a 1 per
Immediately before use, dilute with water R to 100 times cent V/V solution of hydrochloric acid R.
its volume a solution containing aluminium potassium Calcium standard solution (400 ppm Ca). 5000800.
sulphate R equivalent to 0.352 g of AlK(SO4)2,12H2O and
10 ml of dilute sulphuric acid R in 100.0 ml. Immediately before use, dilute with distilled water R to
10 times its volume a solution in distilled water R containing
Ammonium standard solution (100 ppm NH4). 5000300. calcium carbonate R equivalent to 1.000 g of CaCO3 and
23 ml of 1 M hydrochloric acid in 100.0 ml.
Immediately before use, dilute to 25 ml with water R 10 ml
of a solution containing ammonium chloride R equivalent Calcium standard solution (100 ppm Ca). 5000801.
to 0.741 g of NH4Cl in 1000 ml. Immediately before use, dilute with distilled water R to
Ammonium standard solution (2.5 ppm NH4). 5000301. 10 times its volume a solution in distilled water R containing
calcium carbonate R equivalent to 0.624 g of CaCO3 and
Immediately before use, dilute with water R to 100 times 3 ml of acetic acid R in 250.0 ml.
its volume a solution containing ammonium chloride R
equivalent to 0.741 g of NH4Cl in 1000.0 ml. Calcium standard solution (100 ppm Ca) R1. 5000804.
Immediately before use, dilute with water R to 10 times its
Ammonium standard solution (1 ppm NH4). 5000302. volume a solution containing anhydrous calcium chloride R
Immediately before use, dilute ammonium standard solution equivalent to 2.769 g of CaCl2 in 1000.0 ml of dilute
(2.5 ppm NH4) R to 2.5 times its volume with water R. hydrochloric acid R.

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

Calcium standard solution (100 ppm Ca), alcoholic. Ferrocyanide standard solution (100 ppm Fe(CN)6).
5000802. 5001200.
Immediately before use, dilute with alcohol R to 10 times its Immediately before use, dilute with water R to 10 times its
volume a solution in distilled water R containing calcium volume a solution containing potassium ferrocyanide R
carbonate R equivalent to 2.50 g of CaCO3 and 12 ml of equivalent to 0.20 g of K4Fe(CN)6,3H2O in 100.0 ml.
acetic acid R in 1000.0 ml.
Ferricyanide standard solution (50 ppm Fe(CN)6).
Calcium standard solution (10 ppm Ca). 5000803. 5001300.
Immediately before use, dilute with distilled water R Immediately before use, dilute with water R to 100 times
to 100 times its volume a solution in distilled water R its volume a solution containing potassium ferricyanide R
containing calcium carbonate R equivalent to 0.624 g of equivalent to 0.78 g of K3Fe(CN)6 in 100.0 ml.
CaCO3 and 3 ml of acetic acid R in 250.0 ml. Fluoride standard solution (10 ppm F). 5001400.
Chloride standard solution (50 ppm Cl). 5004100. Dissolve in water R sodium fluoride R previously dried at
300 °C for 12 h, equivalent to 0.442 g of NaF, and dilute to
Immediately before use, dilute with water R to 10 times its 1000.0 ml with the same solvent (1 ml = 0.2 mg F). Store in a
volume a solution containing sodium chloride R equivalent polyethylene container. Immediately before use, dilute the
to 0.824 g of NaCl in 1000.0 ml. solution to 20 times its volume with water R.
Chloride standard solution (8 ppm Cl). 5000900. Fluoride standard solution (1 ppm F). 5001401.
Immediately before use, dilute with water R to 100 times its Immediately before use, dilute fluoride standard solution
volume a solution containing sodium chloride R equivalent (10 ppm F) R to 10 times its volume with water R.
to 1.32 g of NaCl in 1000.0 ml.
Formaldehyde standard solution (5 ppm CH2O). 5001500.
Chloride standard solution (5 ppm Cl). 5000901. Immediately before use, dilute with water R to 200 times
Immediately before use, dilute with water R to 100 times its its volume a solution containing 1.0 g of CH2O per litre
volume a solution containing sodium chloride R equivalent prepared from formaldehyde solution R.
to 0.824 g of NaCl in 1000.0 ml.
Germanium standard solution (100 ppm Ge). 5004400.
Chromium liposoluble standard solution (1000 ppm Cr). Dissolve ammonium hexafluorogermanate (IV) R
5004600. equivalent to 0.307 g of (NH4)2GeF6 in a 0.01 per cent V/V
A chromium (metal) organic compound in an oil. solution of hydrofluoric acid R. Dilute the clear solution to
1000 ml with water R.
Chromium standard solution (0.1 per cent Cr). 5001002.
Glyoxal standard solution (20 ppm C2H2O2). 5003700.
Dissolve potassium dichromate R equivalent to 2.83 g of
K2Cr2O7 in water R and dilute to 1000.0 ml with the same In a 100 ml graduated flask weigh a quantity of glyoxal
solvent. solution R corresponding to 0.200 g of C2H2O2 and make up
to volume with ethanol R. Immediately before use dilute the
Chromium standard solution (100 ppm Cr). 5001000. solution to 100 times its volume with the same solvent.
Dissolve potassium dichromate R equivalent to 0.283 g of Glyoxal standard solution (2 ppm C2H2O2). 5003701.
K2Cr2O7 in water R and dilute to 1000.0 ml with the same Immediately before use, dilute glyoxal standard solution
solvent. (20 ppm C2H2O2) R to 10 times its volume with ethanol R.
Chromium standard solution (0.1 ppm Cr). 5001001. Hydrogen peroxide standard solution (10 ppm H2O2).
Immediately before use, dilute chromium standard solution 5005200.
(100 ppm Cr) R to 1000 times its volume with water R. Dilute 10.0 ml of dilute hydrogen peroxide solution R to
300.0 ml with water R. Dilute 10.0 ml of this solution to
Cobalt standard solution (100 ppm Co). 5004300. 1000.0 ml with water R. Prepare immediately before use.
Dissolve cobalt nitrate R equivalent to 0.494 g of
Co(NO3)2,6H2O in 500 ml of 1M nitric acid and dilute the Iodide standard solution (10 ppm I). 5003800.
clear solution to 1000 ml with water R. Immediately before use, dilute with water R to 100 times its
volume a solution containing potassium iodide R equivalent
Copper liposoluble standard solution (1000 ppm Cu). to 0.131 g of KI in 100.0 ml.
5004700.
Iron standard solution (0.1 per cent Fe). 5001605.
A copper (metal) organic compound in an oil.
Dissolve 0.100 g of Fe in the smallest amount necessary
Copper standard solution (0.1 per cent Cu). 5001100. of a mixture of equal volumes of hydrochloric acid R and
water R and dilute to 100.0 ml with water R.
Dissolve copper sulphate R equivalent to 0.393 g of
CuSO4,5H2O in water R and dilute to 100.0 ml with the Iron standard solution (250 ppm Fe). 5001606.
same solvent. Immediately before use, dilute with water R to 40 times its
Copper standard solution (10 ppm Cu). 5001101. volume a solution containing 4.840 g of ferric chloride R in a
150 g/l solution of hydrochloric acid R diluted to 100.0 ml.
Immediately before use, dilute copper standard solution
(0.1 per cent Cu) R to 100 times its volume with water R. Iron standard solution (20 ppm Fe). 5001600.
Immediately before use, dilute with water R to 10 times its
Copper standard solution (0.1 ppm Cu). 5001102. volume a solution containing ferric ammonium sulphate R
Immediately before use, dilute copper standard solution equivalent to 0.863 g of FeNH4(SO4)2,12H2O and 25 ml of
(10 ppm Cu) R to 100 times its volume with water R. dilute sulphuric acid R in 500.0 ml.

General Notices (1) apply to all monographs and other texts 427
4.1.2. Standard solutions for limit tests EUROPEAN PHARMACOPOEIA 5.0

Iron standard solution (10 ppm Fe). 5001601. Magnesium standard solution (10 ppm Mg). 5001801.
Immediately before use, dilute with water R to 100 times its Immediately before use, dilute magnesium standard solution
volume a solution containing ferrous ammonium sulphate R (100 ppm Mg) R to 10 times its volume with water R.
equivalent to 7.022 g of Fe(NH4)2(SO4)2,6H2O and 25 ml of
dilute sulphuric acid R in 1000.0 ml. Magnesium standard solution (10 ppm Mg) R1. 5001802.
Immediately before use, dilute with water R to 100 times
Iron standard solution (8 ppm Fe). 5001602. its volume a solution containing 8.365 g of magnesium
Immediately before use, dilute with water R to 10 times its chloride R in 1000.0 ml of dilute hydrochloric acid R.
volume a solution containing 80 mg of iron R and 50 ml of
hydrochloric acid R (220 g/l HCl) in 1000.0 ml. Manganese standard solution (100 ppm Mn). 5004500.
Iron standard solution (2 ppm Fe). 5001603. Dissolve manganese sulphate R equivalent to 0.308 g of
MnSO4,H2O in 500 ml of 1M nitric acid and dilute the clear
Immediately before use, dilute iron standard solution solution to 1000 ml with water R.
(20 ppm Fe) R to 10 times its volume with water R.
Mercury standard solution (1000 ppm Hg). 5001900.
Iron standard solution (1 ppm Fe). 5001604.
Dissolve mercuric chloride R equivalent to 1.354 g of HgCl2
Immediately before use, dilute iron standard solution in 50 ml of dilute nitric acid R and dilute to 1000.0 ml with
(20 ppm Fe) R to 20 times its volume with water R. water R.
Lead liposoluble standard solution (1000 ppm Pb).
Mercury standard solution (10 ppm Hg). 5001901.
5004800.
A lead (metal) organic compound in an oil. Immediately before use, dilute with water to 100 times its
volume a solution containing mercuric chloride R equivalent
Lead standard solution (0.1 per cent Pb). 5001700. to 0.338 g of HgCl2 in 250.0 ml.
Dissolve lead nitrate R equivalent to 0.400 g of Pb(NO3)2 in Nickel liposoluble standard solution (1000 ppm Ni).
water R and dilute to 250.0 ml with the same solvent. 5004900.
Lead standard solution (0.1 per cent Pb) R1. 5005400. A nickel (metal) organic compound in an oil.
Dissolve in dilute lead-free nitric acid R a quantity of lead
nitrate R equivalent to 0.400 g of Pb (NO3)2 and dilute to Nickel standard solution (10 ppm Ni). 5002000.
250.0 ml with the same solvent. Immediately before use, dilute with water R to 100 times its
volume a solution containing nickel sulphate R equivalent
Lead standard solution (100 ppm Pb). 5001701. to 4.78 g of NiSO4,7H2O in 1000.0 ml.
Immediately before use, dilute lead standard solution
(0.1 per cent Pb) R to 10 times its volume with water R. Nickel standard solution (0.2 ppm Ni). 5002002.
Immediately before use, dilute nickel standard solution
Lead standard solution (10 ppm Pb). 5001702. (10 ppm Ni) R to 50 times its volume with water R.
Immediately before use, dilute lead standard solution
(100 ppm Pb) R to 10 times its volume with water R. Nickel standard solution (0.1 ppm Ni). 5002001.
Immediately before use, dilute nickel standard solution
Lead standard solution (10 ppm Pb) R1. 5001706. (10 ppm Ni) R to 100 times its volume with water R.
Immediately before use, dilute with water R to 10 times its
volume a solution containing 0.160 g of lead nitrate R in Nitrate standard solution (100 ppm NO3). 5002100.
100 ml of water R, to which is added 1 ml of lead-free nitric Immediately before use, dilute with water R to 10 times its
acid R and dilute to 1000.0 ml. volume a solution containing potassium nitrate R equivalent
Lead standard solution (10 ppm Pb) R2. 5005401. to 0.815 g of KNO3 in 500.0 ml.
Dilute lead standard solution (0.1 per cent Pb) R1 to Nitrate standard solution (10 ppm NO3). 5002101.
100 times its volume with dilute lead-free nitric acid R. Use Immediately before use, dilute nitrate standard solution
within 1 week. (100 ppm NO3) R to 10 times its volume with water R.
Lead standard solution (2 ppm Pb). 5001703. Nitrate standard solution (2 ppm NO3). 5002102.
Immediately before use, dilute lead standard solution
Immediately before use, dilute nitrate standard solution
(10 ppm Pb) R to 5 times its volume with water R.
(10 ppm NO3) R to 5 times its volume with water R.
Lead standard solution (1 ppm Pb). 5001704.
Palladium standard solution (500 ppm Pd). 5003600.
Immediately before use, dilute lead standard solution
(10 ppm Pb) R to 10 times its volume with water R. Dissolve 50.0 mg of palladium R in 9 ml of hydrochloric
acid R and dilute to 100.0 ml with water R.
Lead standard solution (0.5 ppm Pb). 5005402.
Palladium standard solution (20 ppm Pd). 5003602.
Dilute lead standard solution (10 ppm Pb) R2 to 20 times its
volume with dilute lead-free nitric acid R. Use within 1 day. Dissolve 0.333 g of palladium chloride R in 2 ml of warm
hydrochloric acid R. Dilute the solution to 1000.0 ml with
Lead standard solution (0.1 ppm Pb). 5001705. a mixture of equal volumes of dilute hydrochloric acid R
Immediately before use, dilute lead standard solution and water R. Immediately before use dilute to 10 times its
(1 ppm Pb) R to 10 times its volume with water R. volume with water R.
Magnesium standard solution (100 ppm Mg). 5001800. Palladium standard solution (0.5 ppm Pd). 5003601.
Immediately before use, dilute with water R to 10 times Dilute 1 ml of palladium standard solution (500 ppm Pd) R
its volume a solution containing magnesium sulphate R to 1000 ml with a mixture of 0.3 volumes of nitric acid R
equivalent to 1.010 g of MgSO4,7H2O in 100.0 ml. and 99.7 volumes of water R.

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

Phosphate standard solution (200 ppm PO4). 5004200. Sulphate standard solution (10 ppm SO4) R1. 5002801.
Dissolve potassium dihydrogen phosphate R equivalent to Immediately before use, dilute with alcohol (30 per
0.286 g of KH2PO4 in water R and dilute to 1000.0 ml with cent V/V) R to 100 times its volume a solution containing
the same solvent. dipotassium sulphate R equivalent to 0.181 g of K2SO4 in
100.0 ml of alcohol (30 per cent V/V) R.
Phosphate standard solution (5 ppm PO4). 5002200.
Immediately before use, dilute with water R to 100 times Sulphite standard solution (80 ppm SO2). 5005500.
its volume a solution containing potassium dihydrogen Dissolve 3.150 g of anhydrous sodium sulphite R in freshly
phosphate R equivalent to 0.716 g of KH2PO4 in 1000.0 ml. prepared distilled water R and dilute to 100.0 ml with the
same solvent. Dilute 0.5 ml to 100.0 ml with freshly prepared
Platinum standard solution (30 ppm Pt). 5002300. distilled water R.
Immediately before use, dilute with 1 M hydrochloric acid
to 10 times its volume a solution containing 80 mg of Sulphite standard solution (1.5 ppm SO2). 5002900.
chloroplatinic acid R in 100.0 ml of 1 M hydrochloric acid. Dissolve sodium metabisulphite R equivalent to 0.152 g of
Na2S2O5 in water R and dilute to 100.0 ml with the same
Potassium standard solution (600 ppm K). 5005100. solvent. Dilute 5.0 ml of this solution to 100.0 ml with
Immediately before use, dilute with water R to 20 times water R. To 3.0 ml of the resulting solution, add 4.0 ml of
its volume a solution containing dipotassium sulphate R 0.1 M sodium hydroxide and dilute to 100.0 ml with water R.
equivalent to 2.676 g of K2SO4 in 100.0 ml.
Thallium standard solution (10 ppm Tl). 5003000.
Potassium standard solution (100 ppm K). 5002400. Dissolve thallous sulphate R equivalent to 0.1235 g of
Immediately before use, dilute with water R to 20 times Tl2SO4 in a 9 g/l solution of sodium chloride R and dilute
its volume a solution containing dipotassium sulphate R to 1000.0 ml with the same solution. Dilute 10.0 ml of the
equivalent to 0.446 g of K2SO4 in 100.0 ml. solution to 100.0 ml with the 9 g/l solution of sodium
Potassium standard solution (20 ppm K). 5002401. chloride R.
Immediately before use, dilute potassium standard solution Tin liposoluble standard solution (1000 ppm Sn). 5005000.
(100 ppm K) R to 5 times its volume with water R. A tin metal organic compound in an oil.
Selenium standard solution (100 ppm Se). 5002500. Tin standard solution (5 ppm Sn). 5003100.
Dissolve 0.100 g of selenium R in 2 ml of nitric acid R. Dissolve tin R equivalent to 0.500 g of Sn in a mixture of
Evaporate to dryness. Take up the residue in 2 ml of water R 5 ml of water R and 25 ml of hydrochloric acid R and dilute
and evaporate to dryness ; carry out three times. Dissolve to 1000.0 ml with water R. Dilute the solution to 100 times
the residue in 50 ml of dilute hydrochloric acid R and dilute its volume with a 2.5 per cent V/V solution of hydrochloric
to 1000.0 ml with the same acid. acid R immediately before use.
Selenium standard solution (1 ppm Se). 5002501. Tin standard solution (0.1 ppm Sn). 5003101.
Immediately before use, dilute with water R to 40 times its Immediately before use, dilute tin standard solution (5 ppm
volume a solution containing selenious acid R equivalent to Sn) R to 50 times its volume with water R.
6.54 mg of H2SeO3 in 100.0 ml.
Titanium standard solution (100 ppm Ti). 5003200.
Silver standard solution (5 ppm Ag). 5002600. Dissolve 100.0 mg of titanium R in 100 ml of hydrochloric
Immediately before use, dilute with water R to 100 times its acid R diluted to 150 ml with water R, heating if necessary.
volume a solution containing silver nitrate R equivalent to Allow to cool and dilute to 1000 ml with water R.
0.790 g of AgNO3 in 1000.0 ml.
Vanadium standard solution (1 g/l V). 5003300.
Sodium standard solution (200 ppm Na). 5002700. Dissolve in water R ammonium vanadate R equivalent to
Immediately before use, dilute with water R to 10 times its 0.230 g of NH4VO3 and dilute to 100.0 ml with the same
volume a solution containing sodium chloride R equivalent solvent.
to 0.509 g of NaCl in 100.0 ml.
Zinc standard solution (5 mg/ml Zn). 5003400.
Sodium standard solution (50 ppm Na). 5002701. Dissolve 3.15 g of zinc oxide R in 15 ml of hydrochloric
Dilute the sodium standard solution (200 ppm Na) R to four acid R and dilute to 500.0 ml with water R.
times its volume with water R.
Zinc standard solution (100 ppm Zn). 5003401.
Strontium standard solution (1.0 per cent Sr). 5003900. Immediately before use, dilute with water R to 10 times its
Cover with water R, strontium carbonate R equivalent to volume a solution containing zinc sulphate R equivalent to
1.6849 g of SrCO3. Cautiously add hydrochloric acid R until 0.440 g of ZnSO4,7H2O and 1 ml of acetic acid R in 100.0 ml.
all the solid has dissolved and there is no sign of further
effervescence. Dilute to 100.0 ml with water R. Zinc standard solution (10 ppm Zn). 5003402.
Immediately before use, dilute zinc standard solution
Sulphate standard solution (100 ppm SO4). 5002802. (100 ppm Zn) R to 10 times its volume with water R.
Immediately before use, dilute with distilled water R to
10 times its volume a solution in distilled water R containing Zinc standard solution (5 ppm Zn). 5003403.
dipotassium sulphate R equivalent to 0.181 g of K2SO4 in Immediately before use, dilute zinc standard solution
100.0 ml. (100 ppm Zn) R to 20 times its volume with water R.
Sulphate standard solution (10 ppm SO4). 5002800. Zirconium standard solution (1 g/l Zr). 5003500.
Immediately before use, dilute with distilled water R Dissolve zirconyl nitrate R equivalent to 0.293 g of
to 100 times its volume a solution in distilled water R ZrO(NO3)2,2H2O in a mixture of 2 volumes of hydrochloric
containing dipotassium sulphate R equivalent to 0.181 g acid R and 8 volumes of water R and dilute to 100.0 ml with
of K2SO4 in 100.0 ml. the same mixture of solvents.

General Notices (1) apply to all monographs and other texts 429