ENDOC LifeCare Pvt. Ltd.
Plot No. 4 To 7, Survey No. 53, B/h Saurashtra Paper Board Mill
Phone: 02827 253 690
Fluconazole - EP
||White or almost white crystalline powder.
||Freely soluble in methanol, soluble in acetone and slightly soluble in water.
||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.
||Not More than 10 ppm
|Loss on drying
||Not More than 0.5%
||Not More than 0.1%
|Related substances By HPLC
- Individual known impurity :
- Fluconazole impurity A: NMT 0.4%
- Fluconazole impurity B: NMT 0.3%
- Fluconazole impurity C: NMT 0.1%
- Any single maximum unknown impurities : NMT 0.1%
- Total Impurities : NMT 0.6%
||Not Less than 99.0% and Not More than 101.0 % w/w of C13H12F2N6O, calculated on the dried basis.