Appearance White crystals or crystalline powder
Assay 98.5-101.5%
Specific rotation +13.7°~ +15.1°
PH 5.5-7.0
Loss on drying 0.2% max
Residue on ignition 0.15% max
Chloride 0.05% max
Sulfate 0.03% max
Iron 0.003% max
Heay metals(as Pb) 0.0015% max
Chromatographic purity Total impurity: 2.0% max
Individual impurity: 0.5% max
Appearance White crystals or crystalline powder
Assay 98.5-101.5%
PH 5.5-7.0
Specific rotation (20/D) -29.4°~ -32.8°
Hevy metals(as Pb) 0.0015% max
Chloride 0.05% max
Sulfate 0.03% max
Iron 0.003% max
Loss on drying 0.3% max
Residue on ignition 0.1% max
Appearance White crystals or crystalline powder
Indentification(IR) Conforms to standard spectrum
Assay 98.5-101.0%
Chromatographic purity(TLC) Total impurities: 2.0%max
Individual impurities: 0.5% max
Specific rotation +14.0°~ +15.6°
Chloride(as Cl) 0.05% max
Sulphate 0.02% max
Iron 0.003% max
Heay metals(as Pb) 0.0015% max
Loss on drying 0.2% max
Residue on ignition 0.1% max
Solution transmittance 98.0%min
Appearance White crystals or crystalline powder
Assay 98.5%~101.5%
Speciific rotation -27.6°~-29.0°
PH 5.0-6.5
Chloride 0.02% max
Ammonium 200ppm max
Sulfate 0.02% max
Hevy metals 10PPM max
Arsenic 1 PPM max
Iron 10PPM max
Other amino acids 0.5% max
Residue on ignition 0.1% max
Loss on drying 0.2% max
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
Appearance White crystals or crystalline powder
Assay 98.5%~101.5%
Specific rotation[α]D20 +20.4°~+21.4°
Iron(Fe) 30ppm max
Chloride(Cl) 19.0~19.6%
Sulfate(SO4) 0.03% max
Heay metals, as Pb 15ppm max
Loss on drying 0.40% max
Residue on ignition 0.10% max
Chromatographic purity Any individual impurity 0.5% max
Total impurities 2.0% max
Organic volatile impurities Meets the requirements
PH 5.5-7.0
Appearance White powder
Assay 98.0%
Specific rotation[α]D20 +24.0°~+27.0°
Iron(Fe) 10ppm max
Chloride(Cl) 0.02% max
Ammonium(NH4) 0.02% max
Heay metals, as Pb 10ppm max
Arsenic 1ppm max
Loss on drying 5.0% max
Residue on ignition 0.20% max
Other Amino acids Meets the requirements