L-天冬酰胺 | CP2020 | EP11 | USP2022 |
含量 | ≥98.0% | 99.0~101.0% | 98.0-101.5% |
酸度 | / | 4.0-6.0 | / |
比旋度[a]D20 | +31.0°-+35.0° | +33.7-+36.0 | +33.0°-+36.5° |
比旋度[a]D25 | / | / | / |
溶液外观 | / | clear & colorless | / |
透光 | ≥98.0% | / | / |
铅 | / | / | ≤5PPM |
氯化物 | ≤0.005% | ≤0.02% | / |
铵盐 | ≤0.1% | ≤0.1% | / |
硫酸盐 | ≤0.005% | ≤0.02% | / |
铁盐 | ≤10PPM | ≤10PPM | / |
重金属 | ≤10PPM | / | / |
砷盐 | ≤1PPM | / | / |
其他氨基酸 | ≤0.5% | Impurity A ≤ 0.5% Impurity C ≤ 0.1% each impurity ≤ 0.05% total impurity≤ 0.8% | total impurities≤ 1.0% |
茚三酮活性物质 | / | / | / |
干燥失重 | 11.5%~12.5% | 10.5-12.5% | 11.5-12.5% |
炽灼残渣 | ≤0.10% | ≤0.10% | ≤0.10% |
内毒素 | < 25 EU/g | < 25 EU/g | < 25 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 |