| 甘氨酸 | CP2020 | EP11 | USP2023 |
| 含量 | ≥ 99.0% | 98.5-101.0% | 98.5-101.5% |
| 酸度 | 5.6-6.6 | 5.9-6.4 | / |
| 比旋度[a]D20 | / | / | / |
| 比旋度[a]D25 | / | / | / |
| 透光 | clear & colorless ≥ 98.0% | / | / |
| 溶液外观 | / | clear & not more intensely coloured than reference solution Y7 | / |
| 氯化物 | ≤0.007% | ≤ 75 ppm | ≤0.007% |
| 铵盐 | ≤ 0.02% | ≤0.02% | |
| 硫酸盐 | ≤0.006% | / | ≤0.0065% |
| 铁盐 | ≤0.001% | / | / |
| 重金属 | ≤10PPM | / | / |
| 砷盐 | ≤1PPM | / | / |
| 其他氨基酸 | conform | Impurities B,H,I≤ 0.1% Unspecified impurities≤ 0.1% Total impurities ≤ 0.2% | Glycine anhydride ≤ 0.1% Iminodiacetic acid≤ 0.1% Diglycine≤ 0.1% Triglycine≤ 0.1% Hexamethylenetramine≤ 0.1% Total impurities≤ 1.0% |
| 茚三酮活性物质 | / | Each impurities≤ 0.1% Total impurities≤ 1.0% | / |
| 干燥失重 | ≤0.20% | ≤0.50% | ≤0.20% |
| 炽灼残渣 | ≤0.10% | ≤0.10% | ≤0.10% |
| 内毒素 | ＜ 20 EU/g | ＜ 20 EU/g | ＜ 20 EU/g |
| 总菌 | ≤ 1000 CFU/g | ≤ 1000 CFU/g | ≤ 1000 CFU/g |
| 霉菌&酵母菌 | ≤ 100 CFU/g | ≤ 100 CFU/g | ≤ 100 CFU/g |
| 甘氨酸 | USP32 | AJI92 | FCC5 |
| 含量 | 98.5-101.5% | 98.5-101.0% | 98.5-101.5% |
| 酸度 | / | 5.9-6.4 | / |
| 比旋度[a]D20 | / | / | / |
| 比旋度[a]D25 | / | / | / |
| 透光 | / | ≥98.0% | / |
| 溶液外观 | / | / | / |
| 氯化物 | ≤0.007% | ≤0.007% | / |
| 铵盐 | ≤0.0065% | ≤0.006% | / |
| 硫酸盐 | / | ≤0.02% | / |
| 铁盐 | / | ≤10PPM | / |
| 重金属 | ≤20PPM | ≤10PPM | ≤5PPM |
| 砷盐 | / | ≤1PPM | / |
| 其他氨基酸 | conform | conform | / |
| 茚三酮活性物质 | / | / | / |
| 干燥失重 | ≤0.20% | ≤0.20% | ≤0.20% |
| 炽灼残渣 | ≤0.10% | ≤0.10% | ≤0.10% |
| 内毒素 | / | / | / |
| 总菌 | ≤ 1000 CFU/g | ≤ 1000 CFU/g | ≤ 1000 CFU/g |
| 霉菌&酵母菌 | ≤ 100 CFU/g | ≤ 100 CFU/g | ≤ 100 CFU/g |
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