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 |
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| % 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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