CAS number: 65277-42-1
Molecular formula: C26H28Cl2N4O4
molecular weight: 531.43
Chemical structure:
SR.NO | TEST | SPECIFICATION | RESULTS | |||||
1 | Description | White or almost white powder | Complies | |||||
2 | Solubility | Freely soluble in methylene chloride soluble in methanol, sparingly soluble in ethanol,practically insoluble in water | Complies | |||||
3 | Identification | |||||||
IR | The IR spectrum correspond to Ketoconazole reference standard | Complies | ||||||
4 | Melting point (°C) | Between 148 to 152 | 148‐150 | |||||
5 | Specific rotation (°) | Between ‐1° and +1° | ‐0.02 | |||||
6 | Loss on drying (% w/w) | Not more than 0.5 | 0.31 | |||||
7 | Residue on ignition (% w/w) | Not more than 0.1 | 0.04 | |||||
8 | Heavy metals (%) | Not more than 0.002 | Complies | |||||
9 | Chromatographic purity by TLC | The 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 | |||||
10 | Assay (% w/w) | It content not less than 98.0 and not more than 102.0 on dried basis | 101.51 |