1 | Appearance/Description | Clear, colourless, slightly viscous oily liquid, Fatty odour not more intensely coloured than reference solution Y6. | Clear, colourless, slightly viscous oily liquid, Fatty odour not more intensely coloured than reference solution Y6 |
2 | Solubility | Complies | Soluble in water, miscible with ethanol (96%), toluene alcohol, ether, and with chloroform |
3 | Boiling point | 260°C | About 260°C. |
4 | Identification (By IR) | Complies | IR spectra of the sample should be concomitant with IR spectra of the corresponding standard. |
5 | Identification (By GC) | Complies | The retention time of the triacetin peak of the sample solution corresponds to that of the standard, as obtained in the assay. |
6 | Acidity | Complies | The pink color of the mixture should persist for 15 S |
7 | Relative density, 20°C | 1.161 | 1.159-1.164 |
8 | Refractive index (20°C ± 0.5°C) | 1.431 | 1.429-1.432 |
9 | Assay (On anhydrous basis , by GC) | 99.9% | NLT 97.0% and NMT 102.0% |
10 | Organic impurities: Acetic acid | Not detected | NMT 0.1% |
11 | Organic impurities: Glycerol | Not detected | NMT 0.1% |
12 | Organic impurities: 1-Monoacetin | Not detected | NMT 0.1% |
13 | Organic impurities: 2-Monoacetin | Not detected | NMT 0.1% |
14 | Organic impurities: 1,3-Diacetin | 0.02% | NMT 0.1% |
15 | Organic impurities: 1,2-Diacetin | Not detected | NMT 0.1% |
16 | Organic impurities: Individual, unspecified impurity | 0.03% | NMT 0.1% |
17 | Organic impurities; Total impurities | 0.19% | NMT 0.2% |
18 | Water | 0.14% | NMT 0.2% |
19 | Assay (By Titration) | 99.3% | 97.0% - 100.5% |