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Home Active Pharmaceutical Ingredients ketoconazole
Product Name : Ketoconazole BP/EP/USP
Chemical Name : 1-[4-(4-{[(2R,4S)-2-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]ethan-1-one
CAS Number : 65277-42-1?
Chemical Formula : C26H28Cl2N4O4?
Molecular Mass : 531.43 g/mol
Therapeutic Category : Antifungal

Test Specification
Description A white or off white powder.
Identification Sample spectra should be concordant with Infrared absorption spectrum of Ketoconazole USP working standard
Heavy Metals NMT 0.002%
Loss On Drying Not more than 0.50% under vacuum at 80?c for 4 hrs.
Assay on dried basis by HPLC Between 98.0% and 102.0%
Optical Rotation Between -1.0 to +1.0
Related Substances by HPLC NMT 0.50%
Melting Range Between 148°C to 152°C
Residue On Ignition NMT 0.10% from 2 gm
Methanol (By GC) NMT 3000 ppm
Particle Size For Information
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