ENDOC LifeCare Pvt. Ltd.
Plot No. 4 To 7, Survey No. 53, B/h Saurashtra Paper Board Mill
Phone: 02827 253 690
Fluconazole - USP
||White or almost white, crystalline powder.
||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.
||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%
||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 unknown Impurities : NMT 0.3%
- Total Impurities : NMT 1.5%
||Not Less than 98.0% and Not More than 102.0 % w/w of C13H12F7N60, calculated on the dried basis.