L-色氨酸 | CP2020 | EP11 | USP2023 | AJI92 |
含量 | ≥99.0% | 98.5-101.0% | 98.5-101.5% | 99.0-100.5% |
酸度 | 5.4-6.4 | / | 5.5-7.0 | 5.4-6.4 |
比旋度[a]D20 | -30.0°--32.5° | -30.0°--33.0° | / | -30.5°--32.5° |
比旋度[a]D25 | / | / | -29.4°--32.8° | / |
透光 | ≥95.0% | / | / | ≥95.0% |
溶液外观 | / | clear & colorless ≤BY6 | / | / |
氯化物 | ≤0.02% | ≤0.02% | ≤0.05% | ≤0.02% |
铵盐 | ≤0.02% | ≤0.02% | / | ≤0.02% |
硫酸盐 | ≤0.02% | ≤0.03% | ≤0.03% | ≤0.02% |
铁盐 | ≤20PPM | ≤20PPM | ≤30PPM | ≤20PPM |
重金属 | ≤10PPM | / | / | ≤10PPM |
砷盐 | ≤1PPM | / | / | ≤1PPM |
其他氨基酸 | ≤0.50% | Impurity A≤10ppm Sum of impurities with a retention time less than that of Tryptophan <100ppm Sum of impurities with a retention time great than that of Tryptophan and up to 1.8 time of N-acetyltryptophan <300ppm | Total impurities 1≤0.01% Total impurities 2≤0.03% Tryptophan related compound A ≤10PPM | conform |
茚三酮活性物质 | / | Each impurity≤0.2% Total impurities≤0.5% | / | / |
干燥失重 | ≤0.20% | ≤0.50% | ≤0.30% | ≤0.20% |
炽灼残渣 | ≤0.10% | ≤0.10% | ≤0.10% | ≤0.10% |
总菌 | ≤ 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 | 克罗诺杆菌 /肠杆菌 /沙门氏菌 /蜡样芽胞杆菌 /梭状芽胞杆菌 (可根据要求检测) |