L-半胱氨酸盐酸盐一水 | CP2020 | EP11 | USP2023 | AJI92 | L-半胱氨酸盐酸盐无水物 AJI92 |
含量 | ≥98.5% | 98.5-101.0% | 98.5-101.5% | 99.0-100.5% | 98.0-102.0% |
酸度 | 1.5-2.0 | / | / | 1.5-2.0 | 1.5-2.0 |
比旋度[a]D20 | +5.5°-+7.0° | +5.5°-+7.0° | / | +5.5°-+7.0° | +5.6°-+8.9° |
比旋度[a]D25 | / | / | +5.7°-+6.8° | / | / |
透光 | ≥98.0% | / | / | ≥98.0% | ≥98.0% |
溶液外观 | / | clear & colorless ≤BY6 | / | / | / |
氯化物 | 19.8-20.8% | / | / | 19.89-20.29% | / |
铵盐 | / | ≤0.02% | / | ≤0.02% | / |
硫酸盐 | ≤0.02% | ≤0.03% | ≤0.03% | ≤0.02% | / |
铁盐 | ≤10PPM | ≤20PPM | ≤30PPM | ≤10PPM | / |
重金属 | ≤10PPM | / | / | ≤10PPM | ≤10PPM |
砷盐 | ≤1PPM | / | / | ≤1PPM | ≤1PPM |
其他氨基酸 | ≤0.5% | / | Individual impurities≤0.5% Total impurities≤2.0% | Chromatographically not detectable. | Chromatographically not detectable. |
茚三酮活性物质 | / | Each impurity≤ 0.2% Total impurity≤ 1.0% | / | / | / |
干燥失重 | 8.0-12.0% | 8.0-12.0% | 8.0-12.0% | 8.5-12.0% | ≤1.0% |
炽灼残渣 | ≤0.10% | ≤0.10% | ≤0.4% | ≤0.10% | ≤0.1% |
总菌 | ≤ 1000 CFU/g | ≤ 1000 CFU/g | ≤ 1000 CFU/g | ≤ 1000 CFU/g | ≤ 1000 CFU/g |
霉菌&酵母菌 | ≤ 100 CFU/g | ≤ 100 CFU/g | ≤ 100 CFU/g | ≤ 100 CFU/g | ≤ 100 CFU/g |