| Purity (GC) |
≥ 99.0 % |
| Identity (IR) |
conforms |
| Appearance of the substance |
conforms |
| Acidic substances |
conforms |
| Acidity (HCl) |
≤ 0.001 % |
| Density (d 20 °C/20 °C) |
1.320 - 1.332 |
| Density (d 25 °C/25 °C) |
1.318 - 1.322 |
| Refractive index (n 20/D) |
1.423 - 1.425 |
| Free chlorine (Cl) |
conforms |
| Ethanol,2-Methyl-2-butene and volatile impurities (GC) (Ethanol) |
≤ 2.0 % (v/v) |
| Ethanol,2-Methyl-2-butene and volatile impurities (GC) (2-Methyl-2-buten) |
≤ 0.03 % (v/v) |
| Ethanol,2-Methyl-2-butene and volatile impurities (GC) (Carbon tetrachloride (impurity A)) |
≤ 0.001 % (v/v) |
| Ethanol,2-Methyl-2-butene and volatile impurities (GC) (Chloroform (impurity B)) |
≤ 0.005 % (v/v) |
| Ethanol,2-Methyl-2-butene and volatile impurities (GC) (Total of impurities other than ethanol and 2-methyl-2-butene) |
≤ 0.1 % (v/v) |
| Ethanol,2-Methyl-2-butene and volatile impurities (GC)(reportingthreshold) |
≤ 0.005 % (v/v) |
| 1,1-Dichloroethene (GC) |
≤ 0.03 % |
| 1,2-Dichloroethene (GC) |
≤ 0.03 % |
| Other residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Evaporation residue |
≤ 0.002 % |
| Water |
≤ 0.020 % |
| Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). The product is stabilized with about 50 ppm 2-Methyl-2-butene. Conforms to Ph Eur, BP, NF. |
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