API TESTING SPECIFICATION

Name: Miconazole nitrate USP

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

Code: HMZN

CAS: 22832-87-7

Storage: Preserve in well-closed containers, protected from light.

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

M.F.:  C18 H14 CI4 N2 O. HNO3

M.W.: 479.14g/mole

 

Test

 

Specification

Characters

:

White or practically white, crystalline powder, having not more than a slight odor.It should  melt between 1780C to 1830C, with decomposition.

Solubility

:

Insoluble in ether; very slightly soluble in water and in isopropyl alcohol; slightly soluble in alcohol, in chloroform, and in propylene glycol; sparingly soluble in methanol; soluble in dimethylformamide; freely soluble in dimethylsulfoxide. 

Identification A      (By IR)

:

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

Identification B

:

The UV absorption spectra of the test solution and standard solution should exhibit maxima and minima at same wavelengths (+ 3%) and absorptivities and/or absorbance ratios should be within specified limit.

Loss on drying

:

Not more than 0.50%w/w

Residue on ignition

:

Not more than 0.200%w/w

Related compounds (HPLC)

:

Any individual impurity: NMT 0.25%.
Total impurities: NMT 0.50%.

     

Residual solvents

:

Toluene not more than 890.00 ppm
Methanol not more than 3000.00 ppm

Assay

:

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

End of specification