| 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% | / | / |
| 溶液外觀 | / | clear & not more intensely coloured than reference solution Y7 | / |
| 氯化物 | ≤0.007% | ≤ 75 ppm | ≤0.007% |
| 銨鹽 | ≤ 0.02% | ≤0.02% | |
| 硫酸鹽 | ≤0.006% | / | ≤0.0065% |
| 鐵鹽 | ≤0.001% | / | / |
| 重金屬 | ≤10PPM | / | / |
| 砷鹽 | ≤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% |
| 茚三酮活性物質(zhì) | / | Each impurities≤ 0.1% Total impurities≤ 1.0% | / |
| 干燥失重 | ≤0.20% | ≤0.50% | ≤0.20% |
| 熾灼殘渣 | ≤0.10% | ≤0.10% | ≤0.10% |
| 內(nèi)毒素 | ＜ 20 EU/g | ＜ 20 EU/g | ＜ 20 EU/g |
| 總菌 | ≤ 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% | / |
| 溶液外觀 | / | / | / |
| 氯化物 | ≤0.007% | ≤0.007% | / |
| 銨鹽 | ≤0.0065% | ≤0.006% | / |
| 硫酸鹽 | / | ≤0.02% | / |
| 鐵鹽 | / | ≤10PPM | / |
| 重金屬 | ≤20PPM | ≤10PPM | ≤5PPM |
| 砷鹽 | / | ≤1PPM | / |
| 其他氨基酸 | conform | conform | / |
| 茚三酮活性物質(zhì) | / | / | / |
| 干燥失重 | ≤0.20% | ≤0.20% | ≤0.20% |
| 熾灼殘渣 | ≤0.10% | ≤0.10% | ≤0.10% |
| 內(nèi)毒素 | / | / | / |
| 總菌 | ≤ 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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