clemastine fumarate clemastine hydrogen fumarate CLEMASTINE
clemastine fumarate :
Items |
Standard |
---|---|
Identification |
IR, TLC |
Appearance |
White or off-white crystalline powder |
Specific Rotation |
+15°~+18° |
PH |
3.2~4.2 |
Loss on drying |
≦0.5% |
Heavy metals |
≦0.002% |
Related Materials Chromatographic purity |
1、Individual Max impurity, no more than 0.5% 2、Total impurities , no more than 1.0% |
Assay |
98.0~102.0% |
Particle Size Analysis |
≧45 microns ≤20% ≧75 microns ≤10% |
Bulk Density |
Before tapping ≧0.15g/ml After tapping ≧0.35g/ml |
Clemastine N-oxide Fumarate |
< 0.1% |
Alfa-Methyl-P-Chlorobenzhydrol |
< 0.1% |
clemastine fumarate :
Items |
Standard |
---|---|
Identification |
IR, TLC |
Appearance |
White or off-white crystalline powder |
Specific Rotation |
+15°~+18° |
PH |
3.2~4.2 |
Loss on drying |
≦0.5% |
Heavy metals |
≦0.002% |
Related Materials Chromatographic purity |
1、Individual Max impurity, no more than 0.5% 2、Total impurities , no more than 1.0% |
Assay |
98.0~102.0% |
Particle Size Analysis |
≧45 microns ≤20% ≧75 microns ≤10% |
Bulk Density |
Before tapping ≧0.15g/ml After tapping ≧0.35g/ml |
Clemastine N-oxide Fumarate |
< 0.1% |
Alfa-Methyl-P-Chlorobenzhydrol |
< 0.1% |
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