Sr. No. | Description | Specification |
1 | Appearance | White or creamy white crystalline powder |
2 | Solubility | Practically insoluble in water, slightly soluble in benzene and in dietyl ether, sparingly soluble in ethanol, soluble in acetone, in Dimethyl sulphoxide, in chloroform in methanol and in dioxane |
3 | Identification | By IR The Infrared absorption Spectrum of the sample should be concordant with the spectrum obtained from Clobetasol Propionate CRS/WS |
4 | Melting Range | 195 °C to 197 °C |
5 | Specific Rotation | Between +98°C and +104°C |
6 | Loss on drying (in % w/w) | Not more than 2.0% |
7 | Residue on Ignition (in % w/w) | Not more than 0.1% |
8 | Heavy metals | Not more than 20 ppm |
9 | Organic Impurities: Any individual impurity Total impurities |
Not more than 1.0% Not more than 2.5% |
10 | Assay (on dried basis in % w/w) | NLT 97.0% and NMT 102.0% |