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RISPERIDONE
Characteristics: The sample is crystalline powder.
Idenfification: A, B, C it apperars positive reaction.
Test:
Item |
standard |
Results |
Description |
White to crystalline powder |
conformed |
Solubility |
Practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in ethanol |
Conformed |
Heavy metals |
≤10ppm |
<10ppm |
Arsenic |
≤10ppm |
<1ppm |
Loss on drying |
≤0.5% |
0.05% |
Residue on lgnition(anhydrous) |
≤0.1% |
0.02% |
Related substances
Single impurity
Total impurity |
≤0.2%
≤0.3% |
0.10%
0.12% |
Assay |
99.0%-101.0% |
99.6% |
Conclusion: The sample meets the specifications
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