Specifications | |
---|---|
Assay (m/m) | ≥ 99.2 % |
Assay (V/V) | ≥ 99.5 % |
Identity (IR) | conforms |
Appearance | conforms |
Clarity of solution | conforms |
Colour 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 |
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. Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present. Conforms to Ph Eur, BP, JP, USP |