1 | Description and solubility | Clear colourless mobile liquid having an odor resembling that of choloroform. Miscible with alcohol with ether and with fixed and volatile oils. | Clear, Colourless, mobile liquid, having an odor resembling that of chloroform. Miscible with alcohol, with ether, and with fixed and volatile oils.(USP) |
2 | Appearance | Passes | Clear,colourless, volatile liquid. (Ph.Eur) |
3 | Identification A (By IR) | Complies | To Comply the test (USP) |
4 | Identification A (Relative density, 20°C) | Complies | To Comply the test (Ph.Eur) |
5 | Identification B (Refractive index, 20±0.5°C) | Complies | To Comply the test (Ph.Eur) |
6 | Identification C (By IR) | Complies | To Comply the test (Ph.Eur) |
7 | Identification D (By chemical test) | Complies | To Comply the test (Ph.Eur) |
8 | Identification E (By Chemical test) | Complies | To Comply the test (Ph.Eur) |
9 | Specific gravity,25°C | 1.318 | Between 1.318 and 1.322 (USP) |
10 | Relative density, 20°C | 1.325 | 1.320 to 1.332 (Ph.Eur) |
11 | Refractive index, 20°C ± 0.5°C | 1.423 | 1.423 to 1.425 (Ph.Eur) |
12 | Water | 0.0090% | Not more than 0.02%m/m (USP/Ph.Eur) |
13 | Limit of hydrogen chloride | NMT 0.001% | 0.001% max (USP) |
14 | Limit of Non-volatile residue | 0.0004% | 0.002% max (USP) |
15 | Heavy metals | NMT 1ppm | 1 ppm max (USP/Ph.Eur) |
16 | Free Chlorine (Cl) | Complies | To Comply the test (USP/Ph.Eur) |
17 | Assay | 99.99% | NLT 99.0% (USP) |
18 | Solubility | Passes | Sparingly soluble in water, miscible with ethanol (96%) (Ph.Eur) |
19 | Acidity | Complies | To Comply the test (Ph.Eur) |
20 | Ethanol, 2-methylbut-2-ene and volatile impurities: Ethanol | Not detected | 2.0% v/v max (Ph.Eur) |
21 | Ethanol, 2-methylbut-2-ene and volatile impurities: 2-methylbut-2-ene | 0.002% | 0.03% v/v max(Ph.Eur) |
22 | Impurity A (Carbon tetrachloride) | Not detected | 4 ppm v/v max (Ph.Eur) |
23 | Impurity B (Chloroform) | Not detected | 50ppm v/v max (Ph.Eur) |
24 | Total impurity other than Ethanol and 2-methylbut-2-ene | NMT 0.1% | 0.1% v/v max (Ph.Eur) |
25 | Residue on evaporation | 4ppm | 20ppm max (Ph.Eur) |
26 | Residual solvent (ICH) | Complies | To comply the test |