Test Items项目 Specification质量指标 Assay 含量 ≥99.0% Characteristic性状 White or almost white, crystals or crystalline powder, Odorless, slightly bitter taste. Specific rotation[a]D比旋度 +12.0°~ +12.8° Identification 鉴别 AS PER CP2010 PH酸度 7.0~8.5 Transmittance溶液透光率 ≥98.0% Chloride氯化物 ≤0.02% Sulfate硫酸盐 ≤0.02% Ammonium铵盐 ≤0.02% Other amino acids其他氨基酸 ≤0.5% Loss on drying干燥失重 ≤0.2% Residue on ignition炽灼残渣 ≤0.1% Iron铁盐 ≤0.001% Heavy metals(as Pb)重金属 ≤10ppm Arsenic砷盐 ≤0.0001% Bacterial endotoxins细菌内毒素 ≤6.0 EU/g
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