COA 质检单预览
您好！这是该产品的电子版质检报告，您可以打印或导出为 PDF。
宁波英诺泰科生物科技有限公司
Ningbo Inopha Biotec Ltd.
质检单 CERTIFICATE OF ANALYSIS
| 产品名称 Product name | 丙氨酸 / Alanine | ||
| 生产日期/ Manufacturing date | 2025.06.19 | CAS No. | 6898-94-8 |
| 报告日期/ Reporting date | 2025.06.23 | 批号/ Batch No. | AL842-052506192 |
| 有效期/ Expiry date | 2027.06.18 | 重量/ Quantity | |
| 检测项目 / Item | 检测标准 / Standard | 检测结果 / Result |
|---|---|---|
| 性状 / Description | 应为白色或类白色结晶或结晶性粉末；有香气。本品在水中易溶，在乙醇、丙酮或乙醚中不溶；在 1 mol/L 的盐酸溶液中易溶。 / Should be white or almost white crystalline or crystalline powder; fragrant. Freely soluble in water, insoluble in ethanol, acetone or ether; freely soluble in 1 mol/L hydrochloric acid solution. | 为白色结晶性粉末；有香气。本品在水中易溶，在乙醇、丙酮或乙醚中不溶；在 1 mol/L 的盐酸溶液中易溶。 / White crystalline powder; fragrant. Freely soluble in water, insoluble in ethanol, acetone or ether; freely soluble in 1 mol/L hydrochloric acid solution. |
| 比旋度 / Specific Rotation | 应为 +14.0° ~ +15.0° / Should be +14.0° to +15.0° | 为 +14.6° / +14.6° |
| 鉴别 (1) 薄层色谱 / Identification (1) TLC | 供试品溶液所显主斑点的位置和颜色应与对照品溶液的主斑点相同 / The position and color of the principal spot in the test solution should be the same as that in the reference solution. | 与对照品溶液的主斑点相同 / Same as the principal spot of the reference solution. |
| 鉴别 (2) 红外光谱 / Identification (2) IR | 红外光吸收图谱应与对照的图谱（光谱集 915 图）一致 / The infrared absorption spectrum should be consistent with the reference spectrum (Spectrum No. 915). | 与对照的图谱一致 / Consistent with the reference spectrum. |
| 酸度 / Acidity | 应为 5.5 ~ 7.0 / Should be 5.5 to 7.0 | 为 6.2 / 6.2 |
| 溶液的透光率 / Transmittance of solution | 在 430nm 的波长处应不得低于 98.0% / Not less than 98.0% at 430nm wavelength. | 为 99.6% / 99.6% |
| 氯化物 / Chloride | 应不得过 0.02% / Not more than 0.02% | 未过 0.02% / Not more than 0.02% |
| 硫酸盐 / Sulfate | 应不得过 0.02% / Not more than 0.02% | 未过 0.02% / Not more than 0.02% |
| 铵盐 / Ammonium | 应不得过 0.02% / Not more than 0.02% | 未过 0.02% / Not more than 0.02% |
| 其他氨基酸 / Other amino acids | 应不得超过 1 个，不得过 0.5% / Not more than 1 spot, not more than 0.5% | 未过 1 个，未过 0.5% / Not more than 1 spot, not more than 0.5% |
| 干燥失重 / Loss on drying | 应不得过 0.2% / Not more than 0.2% | 为 0.12% / 0.12% |
| 炽灼残渣 / Residue on ignition | 应不得过 0.1% / Not more than 0.1% | 为 0.06% / 0.06% |
| 铁盐 / Iron | 应不得过 0.001% / Not more than 0.001% | 未过 0.001% / Not more than 0.001% |
| 重金属 / Heavy metals | 应不得过百万分之十 / Not more than 10 ppm | 未过百万分之十 / Not more than 10 ppm |
| 砷盐 / Arsenic | 应不得过 0.0001% / Not more than 0.0001% | 未过 0.0001% / Not more than 0.0001% |
| 细菌内毒素 / Bacterial endotoxins | 应小于 20EU/g / Less than 20EU/g | 小于 20EU/g / Less than 20EU/g |
| 含量测定 / Assay | 按干燥品计算，含丙氨酸 (C3H7NO2) 应为 98.5% ~ 101.5% / Calculated on the dried basis, Alanine (C3H7NO2) should be 98.5% to 101.5% | 为 100.2% / 100.2% |
| 检测结论/ Conclusion | 本品按中国药典 2020 年版二部检验，结果符合规定。 / The product was tested according to ChP 2020 Vol II, and the results comply with the requirements. | |
Ningbo Inopha Biotec Ltd. | Website: www.inopha.com
Authorized Signature / Date
© 2026 宁波英诺泰科生物科技有限公司 - 专业化学品质量管理系统