VAT. NL821763611B01 / KVK.

14126081
Gerard Bruningstraat 176416 EA Heerlen. Netherlands
Tel: +31 97010210284 – Email: [email protected]

Page 1 of 3
CERTIFICATE OF ANALYSIS
WORLD/GMP GRADE
ISOPROPYL ALCOHOL, 99%
Meets ACS/USP/FCC/EP/BP/JP Monographs
With USP<232>, EMA and ICH Q3D Elemental Impurities Test Results
Lot#: C17E08007
QC#: WO136412
Date of Manufacture: 03/18/20
Product Packaging: 55 Gallon Metal Drum
Catalog #/Product Code: 231WORLD
Recommended Retest Date: 03/2025
*Valid for all components except UV unless packaged in glass or UV protected drums. Please consult our technical
support department for further information.

Manufactured in compliance with cGMP

MONO-
TEST SPECIFICATION RESULT
GRAPH
Assay (corrected for water) USP 99.0% min
Assay (corrected for water) ACS 99.5% min 99.94%
Assay (wt%) FCC 99.7% min
Appearance EP/BP/JP Clear, colorless liquid Pass
Solubility EP/BP Miscible with water and alcohol
JP Miscible with water, ethanol, methanol, diethyl
Pass
ether
Solubility in water FCC/ACS To Pass Test
Color (APHA) ACS 10 max 1
Purity 1 – Clarity of Solution JP Solution is Clear Pass
Nonvolatile Substances EP/BP NMT 20ppm 0 ppm
Purity 3 - Residue on Evaporation JP NMT 1.0mg / 20mL 0.0 mg/20 mL
Limit of Nonvolatile Residue USP NMT 2.5 mg (0.005%) 0.0 mg
Nonvolatile Residue FCC NMT 10 mg/kg 0 mg/kg
Residue after Evaporation ACS 0.001% max 0.000%
USP 0.783 - 0.787 @ 25°C 0.783
Specific Gravity JP 0.785-0.788 @ 20°C 0.786
FCC NMT 0.7840@ 25°C 0.7832
Identification A - Relative Density@20°C EP/BP 0.785 - 0.789 g/ml 0.785
Identification A – Infrared Absorption USP To Pass Test Pass
Identification C – Infrared Absorption EP/BP Compares to standard Pass
Identification Test 1 Light yellow precipitate is formed Pass
JP
Identification Test 2 Filter paper turns red-brown color Pass
Identification B USP To Pass Test Pass
Identification D EP/BP The entire sulfuric acid layer turns violet Pass
Identification B - Refractive Index@20°C EP/BP 1.376 - 1.379
Identification - Refractive Index @20°C FCC About 1.377 1.377
Refractive Index @ 20°C USP 1.376 - 1.378
Acidity or Alkalinity EP/BP To Pass Test Pass

Form: Isopropanol 99%-ACS/USP/FCC/ EP/BP/JP, Rev. 1.1, 06/16, KAD

Approved by: A. Massar, Quality Control Chemist
Disclaimer: For Industrial/Lab use only. Not intended as a Drug Substance, Medical Device or Disinfectant. Appropriate/legal use of this product is
the responsibility of the user. (Rev. # disclaimer only, rev 3.6, 07/15, PD)
 VAT. NL821763611B01 / KVK. 14126081
Gerard Bruningstraat 176416 EA Heerlen. Netherlands
Tel: +31 97010210284 – Email: [email protected]
Page 2 of 3

MONO-
TEST SPECIFICATION RESULT
GRAPH
Acidity USP NMT 0.7ml of 0.020N NaOH is required 0.20 mL
Purity 2 – Acidity JP To pass the test Pass
Acidity (as Acetic Acid) FCC NMT 10 mg/kg < 10 mg/kg
Titrable Acid or Base ACS 0.0001 meq/g < 0.0001 meq/g
Propionaldehyde 0.002% max
Carbonyl Compounds ACS Pass
Acetone 0.002% max
Benzene and related substances
Benzene (by GC) EP/BP NMT 2ppm 1 ppm
Total of Impurities (by GC) NMT 0.3 % < 0.1%
Inorganic Impurities - Lead FCC NMT 1 mg/kg < 1 mg/kg
Substances Reducing Permanganate FCC The pink color is not entirely discharged Pass
Measured between 230 nm and 310 nm
230nm 0.30max. 0.09
250nm 0.10max 0.02
270nm 0.03max 0.00
Absorbance EP/BP
290nm 0.02max 0.00
310nm 0.01max 0.00
The spectrum shows a steadily descending curve Pass
with no observable peaks or shoulders
Diethyl Ether NMT 0.1% <0.1%
Acetone NMT 0.1% None Detected
Diisopropyl Ether NMT 0.1% <0.1%
Limit of Volatile Impurities USP
n-Propyl Alcohol NMT 0.1% <0.1%
2-Butanol NMT 0.1% <0.1%
Total NMT 1.0% <0.1%
Peroxides Test EP/BP No color develops Pass
Distilling Range 81 – 83°C JP More than 94% (vol) Pass
Distillation Range, 1°C inc. 82.3°C FCC To Pass Test Pass
Water, wt % EP/BP NMT 0.5%
Water, wt/v% JP NMT 0.75%
0.01%
Water, wt% FCC/ACS NMT 0.2%
Water Determination USP NMT 0.5%
 Permitted Concentrations of Elemental Impurities Following Option 1 Guideline in drug
products, drug substances and excipients1
Reported in µg/g (ppm)
Parenteral RESULT
Oral Concentration Inhalation
Element Class Concentration (in µg/g)
μg/g Concentration μg/g
μg/g (ppm)
Cd (Cadmium) 1 0.5 0.2 0.2 0.00
Pb (Lead) 1 0.5 0.5 0.5 0.00
As (Arsenic) 1 1.5 1.5 0.2 0.00
Hg (Mercury) 1 3 0.3 0.1 0.00
Co (Cobalt) 2A 5 0.5 0.3 0.00
V (Vanadium) 2A 10 1 0.1 0.00
Ni (Nickel) 2A 20 2 0.5 0.00
Tl (Thallium) 2B 0.8 0.8 0.8 0.00
Au (Gold) 2B 10 10 0.1 0.00
Pd (Palladium) 2B 10 1 0.1 0.00
Ir (Iridium) 2B 10 1 0.1 0.00
Os (Osmium) 2B 10 1 0.1 0.00
Rh (Rhodium) 2B 10 1 0.1 0.00
Ru (Ruthenium) 2B 10 1 0.1 0.00
Se (Selenium) 2B 15 8 13 0.00
Ag (Silver) 2B 15 1 0.7 0.00
Pt (Platinum) 2B 10 1 0.1 0.00
Li (Lithium) 3 55 25 2.5 0.00
Sb (Antimony) 3 120 9 2 0.00
Ba (Barium) 3 140 70 30 0.00
Mo (Molybdenum) 3 300 150 1 0.00
Cu (Copper) 3 300 30 3 0.00
Sn (Tin) 3 600 60 6 0.00
Cr (Chromium) 3 1100 110 0.3 0.00

1
Includes all requirements for ICH Q3D-Step 4 version, EMA (EP) 5.2 and USP <232> and <233> General Chapters.