1 | Appearance | Clear,colourless, volatile liquid having an odor resembling that of chloroform. | Clear,colourless, volatile liquid having an odor resembling that of chloroform. |
2 | Solubility | Complies | Sparingly soluble in water, miscible with ethanol (96%) alcohol, with ether, and with fixed and volatile oils. |
3 | Identification A (Relative density, 20°C) | 1.322 | 1.320 to 1.332 |
4 | Identification B (Refractive index, 20±0.5°C) | 1.424 | 1.423 to 1.425 |
5 | Identification C (By IR) | Complies | IR Spectra of the sample should be concomitant with IR spectra of the corresponding standard. |
6 | Identification D (By chemical test) | Complies | A violet color should produce. |
7 | Identification E (By Chemical test) | Complies | The precipitate should dissolve easily with the possible exception of a few large particles which dissolve slowly. |
8 | Appearance of solution | Complies | Clear and colorless |
9 | Relative density, 20°C | 1.322 | 1.320 to 1.332 |
10 | Specific gravity,25°C | 1.320 | Between 1.318 and 1.322 |
11 | Refractive index, 20°C ± 0.5°C | 1.424 | 1.423 to 1.425 |
12 | Assay | 99.98% | NLT 99.0% |
13 | Acidity | Complies | Not more than 0.15 mL of 0.1M sodium hydroxide is required to change the color of the indicator to blue. ( |
14 | Limit of hydrogen chloride | Less than 0.001% | NMT 0.001% |
15 | Free Chlorine (Cl) | Complies | The lower layer does not show a violet tint. |
16 | Ethanol, 2-methylbut-2-ene and volatile impurities: Ethanol | Not detected | NMT 2.0% v/v |
17 | Ethanol, 2-methylbut-2-ene and volatile impurities: 2-methylbut-2-ene | 18 ppm | NMT 300 ppm v/v |
18 | Impurity A (Carbon tetrachloride) | Not detected | NMT 4 ppm v/v |
19 | Impurity B (Chloroform) | Not detected | NMT 50ppm v/v |
20 | Sum of impurities other than ethanol and 2-methylbut-2-ene | 0.005% | NMT 0.1% v/v |
21 | Residue on evaporation | 8ppm | NMT 20ppm |
22 | Water | 0.0084% | NMT 0.02% m/m |
23 | Total aerobic microbial count | Less than 100 CFU/gm | NMT 100 CFU/gm |
24 | Total combined yeast and molds count | Less than 10 CFU/gm | NMT 10 CFU/gm |
25 | E.coli | Absent/gm | should be absent/gm |
26 | Bacterial endotoxins | Less than 0.1 EU/mg | NMT 0.1 EU/mg |