Ketoconazole

CAS number: 65277-42-1

Molecular formula: C26H28Cl2N4O4

molecular weight: 531.43

Chemical structure:

SR.NOTESTSPECIFICATIONRESULTS
1DescriptionWhite or almost white powderComplies
2SolubilityFreely soluble in methylene chloride soluble in methanol, sparingly soluble in ethanol,practically insoluble in waterComplies
3Identification

IRThe IR spectrum correspond to Ketoconazole reference standardComplies
4Melting point (°C)Between 148 to 152148‐150
5Specific rotation (°)Between ‐1° and +1°‐0.02
6Loss on drying (% w/w)Not more than 0.50.31
7Residue on ignition (% w/w)Not more than 0.10.04
8Heavy metals (%)Not more than 0.002Complies
9Chromatographic purity by TLCThe principal spot obtained from the test solution has
about the same size and RF value as that obtained from
the standard solution,and the sum of the intensities of
any secondary spots obtained from the Test solution does
not exceed the intensity of the principal spot obtained
from the diluted standard solution
Complies
10Assay (% w/w)It content not less than 98.0 and not more than 102.0
on dried basis
101.51