1 | Description | Clear, colourless, syrupy liquid, unctuous to the touch, having a sweet taste. Has not more than a slight characteristic odor, which is neither harsh nor disagreeable. is hygroscopic. Its solutions are neutral to litmus. | Clear, colourless, syrupy liquid, unctuous to the touch, having a sweet taste. Has not more than a slight characteristic odor, which is neither harsh nor disagreeable. Is hygroscopic. Its solutions are neutral to litmus. |
2 | Solubility | Complies | 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. |
3 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the standard. |
4 | Identification (Diethylene glycol) | Not detected | NMT 0.10% |
5 | Identification (Ethylene glycol) | Not detected | NMT 0.10% |
6 | Identification (By GC Chromatogram) | Complies | The retention time of the glycerine peak of the Sample solution corresponds to that obtained in the Standard solution. |
7 | Identification 1 (By Chemical test) | Complies | Within 10 min, the blue colour does not diffuse into the lower layer. |
8 | Identification 2 (By Chemical test) | Complies | Vapours (acrolein) are evolved which blacken filter paper impregnated with alkaline potassium tetraiodomercurate solution. |
9 | Appearance of solution | Complies | Clear and colorless solution. |
10 | Color | Complies | The colour should not be darker than reference solution. |
11 | Acidity or alkalinity | Complies | Pink colour should produce after adding 0.2 mL of 0.1 mol/L sodium hydroxide solution. |
12 | Refractive index, 20°C | 1.474 | 1.470 - 1.475 |
13 | Relative density (20°C) | 1.259 | 1.258 - 1.268 |
14 | Aldehydes and reducing substances | Complies | The light absorption of the test solution at 655 nm should not be more than that of 2.0 mL of the reference solution. |
15 | Fatty acids and esters | Complies | NMT 2.0 mL of sodium hydroxide (0.1 mol/L) VS should require. |
16 | Related substances: Impurity A (Diethylene glycol) | Not detected | NMT 0.1% |
17 | Related substances: Any other impurity with a retention time less than the retention time of glycerol | 0.05% | NMT 0.1% |
18 | Related substances: Total of all impurities with retention times greater than the retention time of glycerol | 0.01% | NMT 0.5% |
19 | Related substances: Individual impurity | 0.05% | NMT 0.1% |
20 | Related substances: Total impurities | 0.1% | NMT 1.0% |
21 | Halogenated compounds | Less than 35 ppm | NMT 35 ppm |
22 | Sugars | Complies | The solution should remain blue and no precipitate should form. |
23 | Chlorides | Less than 0.0006% | NMT 0.0006% |
24 | Sulphate | Less than 0.002% | NMT 0.002% |
25 | Water | 0.12% | NMT 2.0% |
26 | Residue on ignition | 0.005% | NMT 0.01% |
27 | Assay (Anhydrous basis) | 99.8% | 99.0% - 101.0% |
28 | Chlorinated substances | Less than 0.003% | NMT 0.003% |
29 | Readily carbonizable substances | Complies | Any colour produced should not more intense than that of an equal volume of a reference solution. |
30 | Ammonium | Complies | No odour of ammonia should produced. |
31 | Calcium | Complies | The solution should be clear. |
32 | Iron | Less than 0.00005% | NMT 0.00005% |
33 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
34 | Total combined yeast and mold count | Less than 10 CFU/gm | NMT 10 CFU/gm |
35 | Bacterial endotoxins | Less than 5 EU/gm | NMT 5 EU/gm |
36 | E.coli | Not detected | Should not be detected. |