|
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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