ENDOC LifeCare Pvt. Ltd.
Plot No. 4 To 7, Survey No. 53, B/h Saurashtra Paper Board Mill
Phone: 02827 253 690
Fluconazole - IP
||A white or almost white, crystalline powder.
||Slightly soluble in water.
|Appearance of Solution
||A 5% w/v solution in methanol, the solution is clear and colorless.
||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%
||Not More than 0.1%
||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%
||Not Less than 98.5% and Not More than 101.5 % w/w of C13H12F2N6O, calculated on the dried basis.