Appearance | A white or almost white Crystalline powder |
Solubility | Practically insoluble in water, Freely soluble in alcohol |
Identification | IR-spectrum; TLC |
Related substances(HPLC) | Not More Than 2.0% |
water (K.Fisher) | 1.4%-2.0% |
Sulfated ash | Not more than 0.2% |
Assay | 97.5-101.0% calculated to anhydrous substance |
Residual solvents | Methanol n.m.t 0.3% Butyl acetate n.m.t 0.1% Butanol n.m.t 0.05% |
Biological | Not less than 900U/mg, Calculated with reference to the Anhydrous substance |
water (K.Fisher) | 1.4%-2.0% |