| Assay (m/m) |
≥ 99.2 % |
| Assay (V/V) |
≥ 99.5 % |
| Identity (IR) |
conforms |
| Appearance |
conforms |
| Clarity of solution |
conforms |
| Color of solution |
conforms |
| Acidity or alkalinity |
≤ 30 ppm |
| Density (d 20 °C/20 °C) |
0.790 - 0.793 |
| Density (d 15,56 °C/15,56 °C) |
≤ 0.7962 |
| Density (d 15 °C/15 °C) |
0.794 - 0.797 |
| Specific gravity (d 15 °C/15 °C) |
0.79422 - 0.79679 |
| Absorbance (at 240 nm) |
≤ 0.40 |
| Absorbance (between 250nm and 260nm) |
≤ 0.30 |
| Absorbance (between 270nm and 340nm) |
≤ 0.10 |
| The spectrum shows a steadily descending curve with no observable peaks or shoulders |
conforms |
| Volatile impurities (GC) (Acetaldehyde and Acetal) |
≤ 10 ppm |
| Volatile impurities (GC) (Benzene) |
≤ 2 ppm |
| Volatile impurities (GC) (Methanol) |
≤ 100 ppm |
| Volatile impurities (GC) (Total of other impurities) |
≤ 300 ppm |
| Volatile impurities (GC) (disregard limit) |
≤ 9 ppm |
| Cyclohexane (GC) |
≤ 50 ppm |
| 2-Propanol (GC) |
≤ 30 ppm |
| Evaporation residue |
≤ 25 mg/l |
| Other residual solvents (ICH Q3C) excluded by production process. 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 (*). Conforms to Ph Eur, BP, JP, USP |
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