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

M.F.:  C22 H17 ClN2  

M.W.: 344.84g/mole







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



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.



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

End of specification