Fluconazole - USP

Tests Specification
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
  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 unknown Impurities : NMT 0.3%
  5. 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.