Glycerin USP/Ph.Eur/BP PARENTEX PLUS 2LT Go Back


: 56-81-5

Molecular Formula

: C3H8O3

Molecular Weight

: 92.10
Appearance/Description: Clear, colorless, syrupy liquid, unctuous to the touch. Its solutions are neutral to litmus.
Solubility: Miscible 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.
Identification (by IR): IR spectra of the sample should be concomitant with IR spectra of the standard
Identification (Diethylene glycol): NMT 0.10%
Identification (Ethylene glycol): NMT 0.10%
Identification (By GC Chromatogram): The retention time of the glycerin peak of the sample solution corresponds to that obtained in the standard solution
Identification (By Refractive index, 20±0.5°C): 1.470 - 1.475
Identification (By Relative density): 1.258 - 1.268
Appearance of solution: Clear and colorless solution
Color: Color of the sample should not be darker than the color of the standard
Acidity or Alkalinity: Not more than 0.2 mL of 0.1M sodium hydroxide should require to change the colour of the indicator to pink.
Refractive index,20° C: 1.470 - 1.475
Specific gravity, 25°C: NLT 1.249
Aldehydes: NMT 10 ppm
Impurity A (Diethylene glycol): NMT 0.1%
Related substances (Any impurity with a retention time less than the retention time of glycerol ): NMT 0.1%
Related substances: Total of all impurities with retention times greater than the retention time of glycerol: NMT 0.5%
Related compounds : Individual impurity: NMT 0.1%
Related compounds : Total impurities: NMT 1.0 %
Halogenated compounds: NMT 35 ppm
Sugars: The solution should remain blue, no precipitate should form
Chloride (Cl): NMT 10ppm
Sulphate (SO4): NMT 20ppm
Water: NMT 2.0%
Sulphated ash / Residue on ignition: NMT 0.01%
Assay (Anhydrous basis): 99.0% - 101.0%
Chlorinated compounds (as Cl): NMT 30 ppm of Cl
Fatty acids and esters: NMT 1.0 mL of 0.5N sodium hydroxide should consume.
Ester: Not less than 8.0 mL of 0.1M hydrochloric acid is required to the change the colour of the indicator.
Bacterial endotoxins: NMT 5.0 EU/gm
Total aerobic microbial count: NMT 100 CFU/gm
Total Yeast and mold count: NMT 10 CFU/gm
Escherichia coli: Should be Absent/gm
Salmonella species: Should be Absent/10 gm
Pseudomonas aeruginosa: Should be Absent/gm
Staphylococcus aureus: Should be Absent/gm
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