1 | Description | Syrupy liquid, unctuous to the touch, colourless, clear, very hygroscopic. | Syrupy liquid, unctuous to the touch, colourless or almost colourless, clear, very hygroscopic. |
2 | Solubility | Complies | Miscible with water and ethanol(95%), slightly soluble in acetone, practically insoluble in ether,fatty oils, in essential oils and volatile oil. |
3 | Identification (By IR) | Complies | IR spectra of the sample solution should be concomitant with the reference spectrum of glycerin (85%) |
4 | Identification (By Refractive index, 20±0.5°C) | 1.473 | 1.470 - 1.475 |
5 | Identification (By Relative density) | 1.260 | 1.258-1.268 |
6 | Appearance of solution | Complies | Solution should be clear and colourless. |
7 | Acidity or Alkalinity | Complies | Not more than 0.2ml of 0.1M sodium hydroxide should require to change the colour of the indicator to pink. |
8 | Refractive index,20° C | 1.473 | 1.470 - 1.475 |
9 | Aldehydes | Complies | Any colour produce should not be more intense than that obtained in a standard preparation (NMT 10ppm) |
10 | Ester | Complies | NLT 8.0 ml of 0.1M hydrochloric acid should require to the change the colour of the indicator. |
11 | Related substances (Diethylene glycol) | Not detected | NMT 0.1% |
12 | Related substances (ethylene glycol) | Not detected | NMT 0.1% |
13 | Related substances (Any impurity) | 0.02% | NMT 0.1% |
14 | Related substances (Total impurity) | Not detected | NMT 1.0% |
15 | Related substances (Any impurity with a retention time less than the retention time of glycerol ) | 0.02% | NMT 0.1% |
16 | Related substances: Total of all impurities with retention times greater than the retention time of glycerol | 0.04% | NMT 0.5% |
17 | Halogenated compounds | Less than 35ppm | NMT 35ppm |
18 | Sugars | Complies | The solution should remain blue and no precipitate should produce |
19 | Chlorides | Less than 10ppm | NMT 10ppm |
20 | Heavy metals | Less than 5ppm | NMT 5ppm |
21 | Water | 0.11% | NMT 2.0% |
22 | Sulfated ash | 0.006% | NMT 0.01% |
23 | Assay (on Anhydrous basis) | 99.8% | 98.0% - 101.0% |
24 | Bacterial endotoxin test | Less than 5.0 EU/gm | NMT 5.0 EU/gm |
25 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
26 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm |