Tests
Specifications
Result
Solubility
diffluent in Ach, slightly soluble in methanol,
almost insoluble in chloroformComplies
HPLC
Comply with standard
Complies
A292/A227
2.28~2.42
2.36
IR
IR should comply with the reference standard spectrum.
Complies
citrate
positive
Complies
Acidity
3.0~5.0
3.63
Loss on Drying
≤1.0%
0.32%
Residue on ignition
≤0.1%
0.04%
Heavy Metals
≤20ppm
Complies
Relevant Impurity
≤0.5%
0.28%
Methanol
≤0.3%
0.02%
Methylene dichloride
≤0.06%
0.017%
Assay
98.5~101.5%
99.8%
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