Name: Ketoconazole USP

T.S.No.: SPEC/API/HKTZ-020/D/01
Issue Date: 01/03/2006

Code: HKTZ

CAS: 65277-42-1

Storage: Preserve in well-closed containers.

Supersede: SPEC/API/HKTZ-020/D
Date: 01/04/2002

M.F.:  C26 H28 Cl2 N4 O4

M.W.: 531.43g/mole







White to off-white, crystalline powder.



Freely soluble in dichloromethane, soluble in chloroform and in methanol; sparingly soluble in ethanol (95%); practically insoluble in water and in ether.

Identification       (By IR)


The Infrared absorption spectrum is concordant with the spectrum obtained from working std of Ketoconazole or with the reference Infra red spectrum graph.

Melting range


Between 148.00C to 152.00C.

Specific rotation


Between -1.000 to +1.000 on dried basis.

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 0.002%w/w

Chromatographic Purity


The principal spot obtained from the test solution has about the same size and Rf value as that obtained from the std solution. Sum of the intensity of any secondary spots obtained with test solution should not more intense than the spot in the chromatogram obtained with diluted standard solution. (NMT 2%).

Residual solvents


Ethyl acetate not more than 5000.00 ppm.
Methanol not more than 3000.00 ppm.
Acetone not more than 5000.00 ppm
Dimethyl Sulphoxide not more than 5000.00 ppm



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

End of specification