Item | Specification |
Appearance | Light yellow crystalline powder. |
Solubility | Slightly soluble in water, sparingly soluble in methylene chloride, very slight soluble in ethanol (96%). |
Identification | IR: concordant with the spectrum of reference substance. |
Absorbance | ≤0.20% |
Related substances | Impurity A ≤0.1% Impurity B ≤0.1% Impurity C ≤0.2% Impurity D ≤0.2% Impurity E ≤0.2% Unspecified impurity ≤0.2% Total impurity ≤0.5% |
Heavy metals | ≤20ppm |
Loss on drying | ≤0.5% |
Sulphated ash | ≤0.10% |
Assay | 99.0%-101.0% on dried substance |
Residual solvents | Ethanol ≤5000ppm |
Dichloromethane ≤600ppm |