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Fluticasone Propionate

Appearance:Fine white powder Identification: A. IR B. HPLC Specific rotation, at 20oC, calculated on the anhydrous, solvent-free basis :+32 +36Water :0.2% max Limit of Acetone :1.0% max Organic impurities Impurity A : 0.2% max Impurity B : 0.1% max Impurity C: 0.1% max Impurity D: 0.3% max Impurity E : 0.3% max Any other impurities : 0.1% max Total: 1.0% max

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Clobetasol Propionate

Appearance: White to cream crystalline powderIdentification(IR): Meets the requirementsMelting range: About 196oCSpecific rotation: 98o+104oOrganic Impurities (HPLC)Any individual impurity : 1.0% maxTotal impurities : 2.5% maxLoss on drying: 2.0 % maxResidue on ignition: 0.1 % maxHeavy metals: 20ppm maxAssay (on the dried basis): 97.0 102.0 %Micronization 85+%(by microscope) Residual solvents Methanol: 3000 ppm max. Ethyl acetate: 5000 ppm max. Cyclohexane: 3880 ppm max. Pyridine: 200 ppm max. N.N-Dimethylformamide: 880 ppm max.

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