| Description |
A white or almost white, crystalline powder. |
| Solubility |
Slightly soluble in water. |
| Appearance of Solution |
A 5% w/v solution in methanol, the solution is clear and colorless. |
| Identification |
It responds to the following A & B test |
| 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 0.025% w/v of Fluconazole test solution in methanol in the range of 200 nm to 350 nm should shows absorption maxima at about 266 nm and 261 nm. |
| Loss on drying |
Not More than 0.5% |
| Sulphated ash |
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 Impurities : NMT 1.5%
|
| Assay |
Not Less than 98.5% and Not More than 101.5 % w/w of C13H12F2N6O, calculated on the dried basis. |
