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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