API TESTING SPECIFICATION

Name: Clotrimazole BP

T.S.No.: SPEC/API/HCZ-013/B/01
Issue Date: 01/03/2006

Code: HCZ

CAS: 23593-75-1

Storage: Store protected from light.

Supersede: SPEC/API/HCZ-013/B
Date: 01/04/2002

M.F.:  C22 H17 ClN2

M.W.: 344.80g/mole

 


Test

 

Specification

Characters

:

A white or pale yellow, crystalline powder.

Solubility

:

Practically insoluble in water. soluble in alcohol and in methylene chloride.

Identification

:

Test B or Tests A, C, D.

Identification A

:

Melting point : 141.00C To 145.00C

Identification B

:

The Infra red absorption spectrum should concordant with the spectrum obtained from  Working std  of Clotromazole or with the Reference Infra red spectrum graph.

Identification C

:

The principal spot in the chromatogram obtained with test solution (b) should be similar in position and size to the principal spot in the chromatogram obtained with reference solution (a).

Identification D

:

An orange colour should develop, becoming orange-brown.

Appearance of solution

:

The solution should be clear and not more intensely coloured than reference solution BY6 .

( 2-Chlorophenyl ) diphenylmethanol  (ByTLC)

:

Any spot corresponding to (2-chlorophenyl) - diphenylmethanol in the chromatogram obtained with test solution (a) should not more intense than the spot in the chromatogram obtained with reference solution (b) (0.20%).

Imidazole

:

Any spot corresponding to (imidazole) in the chromatogram obtained with test solution should not more intense than the spot in the chromatogram obtained with reference solution (0.20%).

Loss on drying

:

Not more than 0.50%.

Sulphated Ash

:

Not more than 0.100%.

Assay

:

98.50 to 100.50% w.r.t. dried substance.

End of specification