Product:         Fluconazole      C₁₃H1₂F₂N₆O

Test

Limits

 Description

Solubility

Identification

Melting range

Clarity and color of solution

Related substances HPLC

Heavy metals

Loss on drying

 Sulphated ash

 ASSAY

A white to creamy white crystalline powder.

Soluble in methanol and chloroform, sparingly soluble in acetone and insoluble in water.             

A.       Infrared spectrophotometry as same as Fluconazol CRS.

A.       UV spectrum is as same as Fluconazol CRS.

B.       TLC RF value of test and Fluconazol CRS are the same.

C.       RT main peak in sample solution is the same as in STD solution

136°C - 140°C.

0.2% solution in water is clear and colorless.

The area of any peak apart from the principle peak is not grater than 0.5%, the sum of such

area not grater than 1.0%.

Not more than 20 ppm.

Not more than 1.0 per cent.

Not more than 0.2 per cent.

99.0 - 101.0 % w/w calculated with reference to the dried substance.

This material has been prepared following the good manufacturing practice (G.M.P.) and conforms above specification & requirements of BP2000