Physical state at 20 °C | Solid | Colour | White crystalline |
Melting point/ Freezing point [°C] | 192 °C | Solubility in water [% weight] | 2.500 g/l at 4 °C |
Appearance | Colourless crystals or a white crystalline powder; odourless |
Assay (Potentiometric; on anhydrous basis) | 99.0 – 101.0% |
Identifications | To comply IP tests |
pH (2% w/v solution) | 4.5 to 6.2 |
Related substance (by HPLC) | |
Individual impurity | Max 0.3% |
Sum of all impurities | Max 0.5% |
Specific optical rotation (10% w/v solution) | -0.50° to +0.05° |
Apoatropine (absorbance of a 0.1 per cent w/v solution in 0.01 M hydrochloric acid at about 245 nm) | Max 0.4 |
Foreign alkaloids and decomposition products (by TLC) | To comply IP test |
Sulphated ash | Max 0.2% |
Water (by KF) | Max 4.0% |