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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