Characteristics: White powder Identification :Meets the requirements PH :3.1~4.1 Chromatographic purity Any identified impurity: …
Characteristics: White powder
Identification :Meets the requirements
PH :3.1~4.1
Chromatographic purity Any identified impurity: ≤1.0 %
Any unidentified impurity: ≤0.5 %
Total impurities: ≤3.0 %
Melting point :143℃~152℃
Optical rotation :+24°~ +28°
Fumarate :83.7~87.3mg
Loss on drying :≤0.5 %
Color and clarity of solution:≤0.03(650nm)
≤0.15(400nm)
Limit of residual :solvents Meets the requirements
Residue on ignition :≤0.1%
Heavy metals :≤0.001%
Assay :97.0%~102.0%
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