Test |
|
Specification |
Characters |
: |
A white or almost white powder. |
Solubility |
: |
Practically insoluble in water, freely soluble in methylene chloride, soluble in methanol, sparingly soluble in alcohol. |
Identification |
: |
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 |
Assay |
: |
99.00% to 101.00%w/w on dried substance. |
End of specification |