L-丙氨酸 | CP2020 | EP11 | USP2023 |
含量 | ≥98.5% | 98.5~101.0 % | 98.5-101.5% |
酸度 | 5.5-7.0 | / | 5.5-7.0 |
比旋度[a]D20 | +14.0°-+15.0° | +13.5°-+15.5° | +13.7°-+15.1° |
比旋度[a]D25 | / | / | |
透光 | ≥98.0% | / | / |
溶液外观 | / | clear & colorless ≤BY6 | / |
氯化物 | ≤0.02% | ≤0.02% | ≤0.05% |
铵盐 | ≤0.02% | ≤0.02% | |
硫酸盐 | ≤0.02% | ≤0.03% | ≤0.03% |
铁盐 | ≤10PPM | ≤10PPM | ≤30PPM |
重金属 | ≤10PPM | / | |
砷盐 | ≤1PPM | / | |
其他氨基酸 | ≤0.5% | / | Maleic acid ≤ 0.05% Malic acid ≤ 0.05% Fumaric acid ≤ 0.05% Any unspecified impurity ≤ 0.05% total impurities≤ 0.20% |
茚三酮活性物质 | / | Each impurity≤ 0.1 % Total impurities≤ 0.5 % | |
干燥失重 | ≤0.20% | ≤0.50% | ≤0.20% |
炽灼残渣 | ≤0.10% | ≤0.10% | ≤0.15% |
内毒素 | < 20 EU/g | < 20 EU/g | < 20 EU/g |
总菌 | ≤ 500 CFU/g | ≤ 500 CFU/g | ≤ 500 CFU/g |
霉菌&酵母菌 | ≤ 50 CFU/g | ≤ 50 CFU/g | ≤ 50 CFU/g |