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Glycerin USP/Ph.Eur 200LT
97720LL200329257119IT
USP/Ph.Eur3292571
56-81-567875
(CH2OH)2CHOHSeptember 2020
92.09August 2023
Sr.No.TestResultSpecification
1Appearance/DescriptionClear, colorless, syrupy liquid, unctous to the touch, Its solutions are neutral to litmusClear, colorless, syrupy liquid, unctuous to the touch, Its solutions are neutral to litmus
2SolubilityPassesMiscible with water, ethanol(96%) and with alcohol .slightly soluble in acetone, Insoluble in fatty oils, in essential oils in chloroform, in ether, and in fixed and volatile oils.
3Identification (by IR)CompliesIR spectra of the sample should be concomitant with IR spectra of the corresponding standard
4Identification (Diethylene glycol)Not detectedNMT 0.10%
5Identification (Ethylene glycol)Not detectedNMT 0.10%
6Identification (By GC Chromatogram)CompliesThe retention time of the glycerin peak of the sample solution corresponds to that obtained in the standard solution
7Identification (By Refractive index, 20±0.5°C)1.4721.470 - 1.475
8Identification (By Relative density)1.2601.258-1.268
9Appearance of solutionPassesClear and colorless solution
10ColorPassesColor of the sample should not be darker than the color of the standard
11Acidity or AlkalinityCompliesNot more than 0.2ml of 0.1M sodium hydroxide is required to change the color of the indicator to pink.
12Refractive index,20° C1.4721.470 - 1.475
13Specific gravity, 25°C1.250NLT 1.249
14AldehydesLess than 10ppm10ppm max
15Impurity A (Diethylene glycol)Not detected0.1% max
16Related substances (Any impurity with a retention time less than the retention time of glycerol )0.05%0.1% max
17Related substances: Total of all impurities with retention times greater than the retention time of glycerol0.04%0.5% max
18Related compounds : Individual impurity0.047%NMT 0.1%
19Related compounds : Total impurities0.15%NMT 1.0%
20Halogenated compoundsLess than 35ppm35ppm max
21SugarsPassesThe solution remains blue and no precipitate should form
22ChloridesLess than 10ppm10ppm max
23Sulphate (SO4)Less than 20ppmNMT 20ppm
24Water0.16%2.0% max
25Sulphated ash / Residue on ignition0.003%0.01% max
26Assay (anhydrous substance)99.7%99.0% - 101.0%
27Chlorinated compoundsLess than 30 ppm of ClNMT 30ppm of Cl
28Fatty acids and estersCompliesNMT 1.0ml of 0.5N sodium hydroxide shall consume.
29EsterCompliesNot less than 8.0 ml of 0.1M hydrochloric acid is required to the change the color of the indicator.
Remarks: THE CAPTIONED MATERIAL COMPLIES WITH THE PRESCRIBED QUALITY OF USP AND PH.EUR SPECIFICATION.
FINAR provides this analytical report in good faith and to the best of its knowledge. It should not be substituted for the users own raw material quality control.
Tested By
(Chemist - Quality Control)
Approved By
(Head - Quality Control)
Computer Generated Report - Does not require Signature.
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