| Description |
White or almost white, crystalline powder. |
| Solubility |
Freely soluble in methanol; soluble in alcohol and in acetone; sparingly soluble in isopropanol and in chloroform; slightly soluble in water; very slightly soluble in toluene. |
| Clarity & color of solution |
A 5% w/v solution in methanol, the solution is clear and colorless. |
| Identification |
It responds to the following test A and B |
| A, By IR: - The infrared absorption spectrum of the test substance exhibits maximum at the same wave-length as that of a similar preparation of Fluconazole working reference standard. |
| B, By UV : -The UV absorption spectrum of 200 µg/ml of Fluconazole test solution and Fluconazole standard solution in alcohol should be exhibit maxima at a same wavelength. |
| Loss on drying |
Not More than 0.5% |
| Residue on ignition |
Not More than 0.1% |
| Iron |
Not More than 20 ppm |
| Related substances By HPLC |
- Individual known impurity :
- Fluconazole Related compound A : NMT 0.2%
- Fluconazole Related compound B : NMT 0.1%
- Fluconazole Related compound C : NMT 0.2%
- Impurity at about RRT 0.6 : NMT 1.0%
- Any single maximum unknown impurities : NMT 0.1%
- Total unknown Impurities : NMT 0.3%
- Total Impurities : NMT 1.5%
|
| Assay |
Not Less than 98.0% and Not More than 102.0 % w/w of C13H12F7N60, calculated on the dried basis. |
