| Assay (GC) |
≥ 99.5 % |
| Identity (IR) |
conforms |
| Identity B (USP) |
conforms |
| Identity (JP) |
conforms |
| Appearance |
conforms |
| Clarity of solution |
conforms |
| Acidity or alkalinity |
conforms |
| Acidity |
conforms |
| Refractive index (n 20/D) |
1.376 - 1.378 |
| Density (d 20 °C/20 °C) |
0.785 - 0.788 |
| Density (d 25 °C/25 °C) |
0.783 - 0.787 |
| Boiling range (81-83°C) |
≥ 94 % (v/v) |
| Absorbance (at 230 nm) |
≤ 0.300 |
| Absorbance (at 250 nm) |
≤ 0.100 |
| Absorbance (at 270 nm) |
≤ 0.030 |
| Absorbance (at 290 nm) |
≤ 0.020 |
| Absorbance (at 310 nm) |
≤ 0.010 |
| The spectrum shows a steadily descending curve with no observable peaks or shoulders |
conforms |
| Peroxides |
conforms |
| Volatile Impurities (GC) (individual) |
≤ 0.1 % (v/v) |
| Volatile Impurities (GC) (total) |
≤ 1.0 % (v/v) |
| Benzene and related substances (GC) (Benzene) |
≤ 2 ppm |
| Benzene and related substances (GC) (total of impurities apart from 2-butanol) |
≤ 0.3 % |
| Cyclohexane (GC) |
≤ 50 ppm |
| Acetone (GC) |
≤ 50 ppm |
| Ethanol (GC) |
≤ 50 ppm |
| 1-Propylalcohol (GC) |
≤ 50 ppm |
| Isopropylether (GC) |
≤ 0.01 % |
| Other residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Evaporation residue |
≤ 0.0020 % |
| Water |
≤ 0.20 % |
| 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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