Specifications | |
---|---|
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 |
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 % |
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, JPE, NF |