API TESTING SPECIFICATION

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       

M.W.:479.1g/mole

Specification

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.

178.00C to 184.00C

The Infra red absorption spectrum should concordant with the spectrum obtained from Miconazole nitrate working Standard or reference IR spectrum graph.

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.

Should give the reaction of nitrates.

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

-0.100 to + 0.100

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

NMT 0.50%w/w

NMT 0.100%w/w

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