| Description |
White or almost white crystalline powder. |
| Solubility |
Freely soluble in methanol, soluble in acetone and slightly soluble in water. |
| Identification |
It responds to the following test |
| By IR :- The infrared absorbance spectrum of the test substance is concordant spectrum obtained from similar preparation of Fluconazole working reference Standard. |
| Appearance of solution |
A 5% w/v solution of Fluconazole in methanol should be clear and colorless. |
| Heavy metals |
Not More than 10 ppm |
| Loss on drying |
Not More than 0.5% |
| Sulphated ash |
Not More than 0.1% |
| Related substances By HPLC |
- Individual known impurity :
- Fluconazole impurity A: NMT 0.4%
- Fluconazole impurity B: NMT 0.3%
- Fluconazole impurity C: NMT 0.1%
- Any single maximum unknown impurities : NMT 0.1%
- Total Impurities : NMT 0.6%
|
| Assay |
Not Less than 99.0% and Not More than 101.0 % w/w of C13H12F2N6O, calculated on the dried basis. |
