Refined Glycerine B P

Appearance A syrupy liquid, Unctuous to the touch, colourless or almost colorless, clear, very hygroscopic.
Solubility Miscible with water and with ethanol (96%), slightly soluble in acetone, practically insoluble in fatty oil and in essential oil.
Appearance of Solution Solution S is clear & diluted solution S is colorless.
Identification
  • A) It complies with the test for Refractive Index.
  • B) By IR: The Infra-red absorption spectrum of the resulting solution is concordant with the reference spectrum of Glycerol (85%).
  • C) Relative Density: 1.258 to 1.268
% Assay Not less than 98.0 & not more than 101.0
Acidity/alkalinity (50 mL of 50% w/v solution), Max 0.2 mL of 0.1 M NaOH
Refractive Index at 20°C 1.470 – 1.475
Aldehydes ppm, Max 10.0
Ester Min 8.0 mL 0.1 M HCl
Halogenated Compounds ppm, Max 35.0
Sugars The solution is clear & blue on addition of Copper Sulphate solution R. It remains blue & no precipitate is formed on heating continuously on a water bath for 5 minutes.
Chlorides ppm, Max 10.0
% Water, Max 2.0
% Sulphated Ash, Max 0.01
Impurity A & Related Substances by GC Impurity A = NMT 0.10%
Any other impurities with retention time less than the retention time of glycerol = NMT 0.10%
Total of all impurities with retention time greater than the retention time of Glycerol = NMT 0.5%

Description

Refined Glycerine BP is a pharmaceutical-grade product that is at least 99.5% pure. It is a by-product of splitting natural oil fats during fatty acid production.

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