Fluconazole - EP

Tests Specification
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
  1. Individual known impurity :
    1. Fluconazole impurity A: NMT 0.4%
    2. Fluconazole impurity B: NMT 0.3%
    3. Fluconazole impurity C: NMT 0.1%
  2. Any single maximum unknown impurities : NMT 0.1%
  3. 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.