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Certificate of Analysis
Product Name: Glycerin (Glycerol) Date of Analysis: 03-03-2023 Certified: Kosher and Halal
Product Grade: Pharmaceutical Grade and Food Grade Date of Manufacturing 02-03-2023 COA No: FG23048
Batch No: 0893 CAS# 56-81-5 Temp/Humidity: 24.4°C/51%
Batch Size: 56.00 Tons Expiry Date: 01-03-2025 Sample Receiving 03-03-2023
Document No.: LAB/FM/005; Issue No.: 06; Issue Date: 06-09-2022
TEST NAME SPECIFICATON REFERENCE RESULTS
Description Syrupy liquid, unctuous to the touch, colorless or almost colorless, clear, very hygroscopic. Ph. Eur, BP Complies
Miscible with water and with ethanol (96%), slightly soluble in acetone, practical insoluble in fatty oils
Solubility Ph. Eur, BP Complies
and in essential oils.
Meets Ph. Eur. Complies with test for Refractive Index A. 1.4720
Ph. Eur, BP
1.470 – 1.475 At 20°C Compliance with identification test B (FTIR) and C. Complies
A- Compliance with identification test (FTIR) Complies
Identification B- (Limit of Diethylene Glycol and Ethylene Glycol)
Diethylene Glycol (≤ 0.1 %) USP < 0.1%
Ethylene Glycol (≤ 0.1 %) < 0.1%
C- Compliance with Identification test. Complies
99.0 – 101.0% C3H8O3, Calculated on the Anhydrous basis USP 99.83%
Glycerin (Glycerol)
98.0 – 101.0% Calculated on the Anhydrous basis. Ph. Eur, BP 99.83%
Acidity or Alkalinity Not more than 0.2 ml of 0.1 M Sodium Hydroxide is required to change the color of the indicator to pink. Ph. Eur, BP 0.1
Appearance of Solution The solution is Colorless. Ph. Eur, BP Complies
Odor Not more than a slight characteristic odor. ASTM Complies
Clarity No turbidity or undissolved matter. ASTM Complies
Sugars. The solution remains Blue and No precipitate produced. Ph. Eur. Complies
Halogenated Compounds ≤ 35 ppm Ph. Eur, BP <35
Not darker than 0.40 mL of Ferric Chloride CS diluted to 50ml with water. USP Complies
Color 03
Max 10 Pt. Co Scale (APHA Color Scale) ASTM
Limit of Chlorinated
≤ 0.003 % (NMT 30 ppm) USP <30
Compounds (as Cl), USP
Aldehydes NMT 10 ppm BP, Ph. Eur. <10
Specific Gravity (At 25°C) ≥ 1.249 USP 1.257
Fatty Acids and Esters ≤ 1 mL. Not more than 1 mL of 0.5 N NaOH required for 50 g of sample. USP <1
Esters Not less than 8.0 mL of 0.1 M Hydrochloric Acids is required to change the color of the indicator. BP, Ph. Eur. 9.0
≤ 5.0 % (w/w) USP 0.12%
Water
≤ 2.0 % Ph. Eur, BP 0.12%
≤ 10 ppm Ph. Eur, BP <10
Chlorides 7.0 g shows no more Chloride than) 0.10 mL of 0.02 N Hydrochloric Acid (Not More than 0.001 % Or 10
Inorganic USP <10
ppm of Cl)
Impurities
10.0 g shows no more Sulfate than 0.20 mL of 0.02 N Sulfuric Acid (Not More than 0.002 % or 20 ppm of
Sulfates USP <20
SO4)
≤ 5 ppm Ph. Eur, BP <5
Heavy Metals (Pb)
≤ 5 ppm USP <5
Residue on Ignition Ph. Eur, BP
≤ 0.01 % <0.01 %
(Sulphated Ash) USP
Individual Impurity, USP
≤ 0.1 % USP <0.1%
Ethylene Glycol
Individual Impurity, USP
≤ 0.1 % USP <0.1%
Diethylene Glycol
Related Compounds,
≤ 1.0 % USP <1.0%
Total Impurities, USP
Residual Solvents, USP Meets USP/Ph. Eur. USP/Ph.
Complies
and Ph. Eur. Must meet USP <467> and Ph. Eur. 5.4 requirements for Class 2 residual solvents. Eur.
Meets Ph. Eur, BP
Impurity A: Not more than the area of the corresponding peak in the chromatogram obtained with
reference solution (c) (0.1%), Any other impurity with a retention time less than the retention time of
Impurity A and
Glycerol: Not more than the area of the peak due to Impurity A in the chromatogram obtained with Ph. EUR, BP Complies
Related Substances
reference solution (c) (0.1%) and Total of all impurities with retention times greater than the retention
time of Glycerol: Not more than 5 times the area of the peak due to Impurity A in the chromatogram
obtained with reference solution (c) (0.5%)
Remarks: Material Complies with BP, USP/NF, and Ph. Eur. Specifications. Raw Data Register Number: Lab/FM/007/07 -025 Testing Method No. Lab/DOC/PTM-01
Storage: Store in a tightly closed container.
References: European Pharmacopeia (10th Edition), United States Pharmacopeia 43/ NF 38 & British Pharmacopeia 2020

This is computer generated report and does not require any signature.
Manufacturing Site Address: Plot F-29, NWIZ Port Qasim, Karachi. Website: www.oleocorp.com