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 |