Specifications | |
---|---|
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 % |
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 |