Fluconazole - IP

Tests Specification
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
  1. Individual known impurity :
    1. Fluconazole Related compound A : NMT 0.2%
    2. Fluconazole Related compound B : NMT 0.1%
    3. Fluconazole Related compound C : NMT 0.2%
  2. Impurity at about RRT 0.6 : NMT 1.0%
  3. Any single maximum unknown impurities : NMT 0.1%
  4. 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.