| L-異亮氨酸 | CP2020 | EP11 | USP2023 |
| 含量 | ≥98.5% | 98.5-101.0% | 98.5-101.5% |
| 酸度 | 5.5-6.5 | / | 5.5-7.0 |
| 比旋度[a]D20 | +38.9°-+41.8° | +40.0-+43.0 | / |
| 比旋度[a]D25 | / | / | +38.9°-+41.8° |
| 透光 | ≥98.0% | / | / |
| 溶液外觀 | / | clear & colorless ≤BY6 | / |
| 氯化物 | ≤0.02% | ≤0.02% | ≤0.05% |
| 銨鹽 | ≤0.02% | ≤0.02% | / |
| 硫酸鹽 | ≤0.02% | ≤0.03% | ≤0.03% |
| 鐵鹽 | ≤10PPM | ≤10PPM | ≤30PPM |
| 重金屬 | ≤10PPM | / | / |
| 砷鹽 | ≤1PPM | / | / |
| 其他氨基酸 | ≤0.5% | / |
individual impurities≤0.5% total impurities≤2.0% |
| 茚三酮活性物質(zhì) | / |
Impurities A and C at 570 nm≤ 0.3% each impruity ≤0.2% total ≤1.0% | / |
| 干燥失重 | ≤0.20% | ≤0.5% | ≤0.30% |
| 熾灼殘渣 | ≤0.10% | ≤0.10% | ≤0.30% |
| 內(nèi)毒素 | <20EU/g | <20EU/g | <20EU/g |
| 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 |