Specification Clobetasol Propionate USP

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%