L-精氨酸 | CP2020 | EP11 | USP2023 |
含量 | ≥99.0% | 98.5-101.0% | 98.5-101.5% |
酸度 | 10.5-12.0 | / | / |
比旋度[a]D20 | +26.9°-+27.9° | +25.5°-+28.5° | / |
比旋度[a]D25 | / | / | +26.3°-+27.7° |
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 | ≤0.4% | / | individual impurities≤0.5% total impurities≤2.0% |
茚三酮活性物質(zhì) | / | Each impurity≤0.2% Sum of impurities≤ 0.5% | / |
干燥失重 | ≤0.50% | ≤0.50% | ≤0.50% |
熾灼殘渣 | ≤0.10% | ≤0.10% | ≤0.30% |
內(nèi)毒素 | <10EU/g | <10EU/g | <10EU/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 |