API TESTING SPECIFICATION

Name: Clotrimazole USP

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

Code: HCZ

CAS: 23593-75-1

Storage: Preserve in tight containers.

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

M.F.:  C22 H17 ClN2  

M.W.: 344.84g/mole

 

Test

 

Specification

Characters

:

White to Pale yellow crystalline powder. It should melt at about 1420 with decomposition.

Solubility

:

Practically insoluble in water. Freely soluble in methanol, in acetone, in chloroform and in alcohol.

Identification A     (By IR)

:

The Infra red absorption spectrum should concordant with the spectrum obtained from working std of clotrimazole or with the reference Infra red spectrum graph.

Identification B     (By TLC)

:

The Rf value of the principal spot obtained from the test solution should correspond to that obtained from the standard solution.

Loss on drying

:

Not more than 0.50%w/w.

Residue on Ignition

:

Not more than 0.100%w/w.

Heavy metals

:

Not more than 0.001%w/w.

Limit of Imidazole   ( By TLC )

:

Not more than 0.50%w/w.

Limit of Clotrimazole related compound A ( By HPLC )

:

Not more than 0.500%w/w

 

Residual solvents

:

Diethyl ether not more than 5000.00 ppm.
Acetone not more than 5000.00 ppm.
Methylene chloride not more than 600.00 ppm.
Benzene not more than 2.00ppm.

Assay

:

98.00 % to 102.00% w/w, on dried basis.

End of specification