Name: Ketoconazole BP

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

Code: HKTZ

CAS: 65277-42-1

Storage: Store protected from light.

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

M.F.:  C26 H28 CI2 N4 O4

M.W.: 531.4g/mole







A white or almost white powder.



Practically insoluble in water, freely soluble in methylene chloride, soluble in methanol, sparingly soluble in alcohol.



Test B OR Tests A, C and D.

Identification A (Melting point)        


148.00C to 152.00C

Identification B      


The Infra red absorption spectrum should concordant with the spectrum obtained from Ketoconazole or with the Reference Infra red spectrum graph.

Identification C      


The principal spot in the chromatogram obtained with test solution should be similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a). The test should not valid unless the chromatogram obtained with reference solution (b) shows two clearly separated spots.

Identification D      


The solution gives reaction (a) of chlorides.

Appearance of solution


The 10%w/v solution in methylene chloride should be clear and not more intensely coloured than reference solution BY4.

Optical rotation


- 0.100 to + 0.100

Related substance


Total impurities NMT 0.50%.

Heavy metals


NMT 20 ppm

Loss on drying


NMT 0.50%w/w

Sulphated ash


NMT 0.100%w/w



99.00% to 101.00%w/w on dried substance.

End of specification