| Assay (GC) |
≥ 99.5 % |
| Identity (IR) |
conforms |
| Identity B (NF) |
conforms |
| Identity (JPE) |
conforms |
| Appearance |
conforms |
| Clarity of solution |
conforms |
| Acidity or alkalinity |
conforms |
| Acidity |
conforms |
| Alkalinity (as NH₃) |
≤ 3 ppm |
| Refractive index (n 20/D) |
1.328 - 1.330 |
| Density (d 20 °C/20 °C) |
0.791 - 0.793 |
| Boiling range (64-65°C) |
≥ 95 % (v/v) |
| Absorbance (at 230 nm) |
≤ 0.150 |
| Absorbance (at 250 nm) |
≤ 0.050 |
| Absorbance (at 270 nm) |
≤ 0.020 |
| Absorbance (at 290 nm) |
≤ 0.010 |
| The absorption curve is smooth |
conforms |
| Benzene (impurity A) (GC) |
≤ 2 ppm |
| Acetone (GC) |
≤ 0.001 % |
| Ethanol (GC) |
≤ 0.005 % |
| Ethanol (JPE) |
conforms |
| Related substances (GC) |
conforms |
| Residual solvents class 3 (ICH Q3C) |
< 0.5 |
| Other residual solvents (ICH Q3C) |
excluded by manufacturing process |
| Al (Aluminium)* |
≤ 0.05 ppm |
| Cu (Copper)* |
≤ 0.05 ppm |
| Zn (Zinc)* |
≤ 0.05 ppm |
| Heavy metals |
conforms |
| Aldehydes and Acetone (as acetone) |
≤ 0.003 % |
| Aldehyde and other foreign reducing substances |
conforms |
| Reducing substances |
conforms |
| Readily oxidizable substances |
conforms |
| Readily carbonizable substances |
conforms |
| Readily carbonizable substances (JPE) |
conforms |
| Evaporation residue |
≤ 0.0010 % |
| Water |
≤ 0.10 % |
| 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, JPE, NF |
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