| L-精氨酸鹽酸鹽 | CP2020 | EP11 | USP2023 |
| 含量 | ≥98.5% | 98.5-101.0% | 98.5-101.5% |
| 酸度 | / | / | / |
| 比旋度[a]D20 | +21.5°-+23.5° | +21.0°-+23.5° | +21.4°-+23.6° |
| 比旋度[a]D25 | / | / | / |
| 透光 | ≥98.0% | / | / |
| 溶液外觀 | / | clear & colorless ≤BY6 | / |
| 氯化物 | 16.5-17.1% | / | 16.5-17.1% |
| 銨鹽 | ≤0.02% | ≤0.02% | / |
| 硫酸鹽 | ≤0.02% | ≤0.03% | ≤0.03% |
| 鐵鹽 | ≤10PPM | ≤10PPM | / |
| 重金屬 | ≤10PPM | / | / |
| 砷鹽 | ≤1PPM | / | / |
| 其他氨基酸 | ≤0.20% | / | individual impurities≤0.5% total impurities≤2.0% |
| 茚三酮活性物質(zhì) | / | each impurity≤0.2% total impurity≤0.5% | / |
| 干燥失重 | ≤0.20% | ≤0.50% | ≤0.20% |
| 熾灼殘?jiān)?/td> | ≤0.10% | ≤0.10% | ≤0.10% |
| 蛋白質(zhì) | no precipitate | / | / |
| 內(nèi)毒素 | conform | conform | conform |
| 總菌 | ≤ 500 CFU/g | ≤ 500 CFU/g | ≤ 500 CFU/g |
| 霉菌&酵母菌 | ≤ 50 CFU/g | ≤ 50 CFU/g | ≤ 50 CFU/g |
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