Appearance White crystals or crystalline powder
Assay 98.5-101.5%
PH 5.4-6.0
Specific rotation (20/D) -32.7°~ -34.7°
Heay metals(as Pb) 15ppm max
Chloride 0.05% max
Sulfate 0.03% max
Iron 0.003% max
Loss on drying 0.2% max
Residue on ignition 0.4% max
Appearance White crystals or crystalline powder
Identification IR: Complies with the ref. spectrum
Assay 98.5-101.5%
Chromatagraphic purity Complies
Specific rotation (20/D) -9.8°~ -11.2°
Hevy metals(as Pb) 0.0015% max
Chloride 0.04% max
Sulfate 0.04% max
Iron 0.003% max
Organic volatile impurities Meets the requirement
Loss on drying 0.3% max
Residue on ignition 0.4% max
Appearance White crystals or crystalline powder
Solubility Soluble in water and practically insoluble in alcohol and in ether
Infrared absorption As per FCCVI
Specific rotation [α]D20 +6.3°~ +7.3°
Lead ≤5mg/kg
Loss on drying ≤0.30%
Residue on ignition ≤0.10%
Assay 98.5~101.5%
Melting point 185℃ with decomposition
Appearance White crystals or crystalline powder
Assay 98.5%min
Identification Meet the requirements
Specific rotation [α]D25 +22.4°~+24.7°
Chloride(Cl) 0.05% max
Sulfate(SO4) 0.03% max
Iron(Fe) 0.003% max
Heay metals(Pb) 0.0015% max
Loss on drying 0.30% max
Residue on ignition 0.40%max
Chromatographic purity Not more than 0.5% of any
individual impurity is found;
Not more than 2.0% of total
impurities is found
Organic volatile impurities Meets the requirements
pH 5.6~6.1