KOHINOOR GROUP OF INDUSTRIES

 

SPECIFICATION
 

QUALITY CONTROL DEPARTMENT,

FLUCONAZOLE USP

SPECIFICATION NO.

 

: KIPH/FLU

PAGE NO.

: 1 OF 1

ALL TEST AS PER USP

TEST

REQUIREMENTS

Description

White to almost white, crystalline powder.

Solubility

 

 

 

a) Clarity and Colour of Solution

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


Clear and colourless

 

Identification

IR Absorption

The spectrum should be Concordant with reference standard sample.

Melting Range

138.0 0C  TO 142.0 0C

Loss on Drying(at1050C)

NMT  0.50 % w/w

Residue Ignition

NMT 0.10 %

Iron

NMT 0.002 %

Assay (By HPLC)

NLT 98.50%NMT 101.50%

Related Substance (By HPLC)

a)      Single Impurity

b)     Sum of Impurities

 

 

NMT 0.10%

NMT 0.30%



Issue: KIPH/01                                     More Details write us: kohinoorchem@gmail.com                         01.04.04

 

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