Name: Miconazole nitrate BP

T.S.No.: SPEC/API/HMZN-022/B/01
Issue Date: 01/03/2006

Code: HMZN

CAS: 22832-87-7

Storage: Store protected from light.

Supersede: SPEC/API/HMZN-022/B
Date: 01/04/2002

M.F.:  C18 H14 CI4 N2O, HNO3       








A white or almost white powder.



Very slightly soluble in water, sparingly soluble in methanol, slightly soluble in alcohol.



Test A and B OR Tests A, C and D.

Identification A (Melting point)


178.00C to 184.00C

Identification B       


The Infra red absorption spectrum should concordant with the spectrum obtained from Miconazole nitrate working Standard or reference IR 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) should show two clearly separated spots.

Identification D       


Should give the reaction of nitrates.

Appearance of solution


A 1% w/v Solution should be clear and not more intensely coloured than reference solution Y7.

Optical rotation


-0.100 to + 0.100

Related substance  (By HPLC )


Individual impurity: NMT 0.25%.
Total impurities: NMT 0.50%.

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