L-半胱氨酸鹽酸鹽一水 | CP2020 | EP11 | USP2023 | AJI92 |
含量 | ≥98.5% | 98.5-101.0% | 98.5-101.5% | 99.0-100.5% |
酸度 | 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° |
比旋度[a]D25 | / | / | +5.7°-+6.8° | / |
透光 | ≥98.0% | / | / | ≥98.0% |
溶液外觀 | / | clear & colorless ≤BY6 | / | / |
氯化物 | 19.8-20.8% | / | / | 19.89-20.29% |
銨鹽 | / | ≤0.02% | / | ≤0.02% |
硫酸鹽 | ≤0.02% | ≤0.03% | ≤0.03% | ≤0.02% |
鐵鹽 | ≤10PPM | ≤20PPM | ≤30PPM | ≤10PPM |
重金屬 | ≤10PPM | / | / | ≤10PPM |
砷鹽 | ≤1PPM | / | / | ≤1PPM |
其他氨基酸 | ≤0.5% | / | Individual impurities≤0.5% Total impurities≤2.0% | Chromatographically not detectable. |
茚三酮活性物質(zhì) | / | 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% |
熾灼殘渣 | ≤0.10% | ≤0.10% | ≤0.4% | ≤0.10% |
總菌 | ≤ 500 CFU/g | ≤ 500 CFU/g | ≤ 500 CFU/g | ≤ 500 CFU/g |
霉菌&酵母菌 | ≤ 50 CFU/g | ≤ 50 CFU/g | ≤ 50 CFU/g | ≤ 50 CFU/g |
致病菌 | 克羅諾桿菌 /腸桿菌 /沙門氏菌 /蠟樣芽胞桿菌 /梭狀芽胞桿菌 (可根據(jù)要求檢測) |