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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 | 门冬氨酸 / Aspartic Acid | ||
| 生产日期/ Manufacturing date | 2025.03.20 | CAS No. | 56-84-8 |
| 报告日期/ Reporting date | 2025.03.28 | 批号/ Batch No. | AS785-082503201 |
| 有效期/ Expiry date | 2027.03.19 | 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；无臭。本品在水中微溶；在乙醇中不溶，在稀盐酸或氢氧化钠溶液中溶解。 / Should be white or almost white crystals or crystalline powder; odorless. Slightly soluble in water; insoluble in ethanol; soluble in dilute hydrochloric acid or sodium hydroxide solution. | 本品为白色结晶性粉末；无臭。在水中微溶；在乙醇中不溶，在稀盐酸、氢氧化钠溶液中溶解。 / White crystalline powder; odorless. Slightly soluble in water; insoluble in ethanol; soluble in dilute hydrochloric acid or sodium hydroxide solution. |
| 比旋度 / Specific rotation | 应为+24.0° ~ +26.0° / Should be +24.0° to +26.0° | 为+24.9° / +24.9° |
| 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 chromatogram obtained with the test solution should correspond to those of the principal spot in the chromatogram obtained with the reference solution. | 与对照品溶液的主斑点相同 / Corresponds to 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 913 图）一致 / The IR absorption spectrum should be consistent with the reference spectrum (Spectrum No. 913). | 与对照的图谱一致 / Consistent with the reference spectrum. |
| 酸度 / Acidity | 应为 2.0~4.0 / Should be 2.0 to 4.0 | 为 3.0 / 3.0 |
| 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. | 为 99.3% / 99.3% |
| 氯化物 / Chlorides | 应不得过 0.02% / Not more than 0.02% | 未过 0.02% / Less than 0.02% |
| 硫酸盐 / Sulphates | 应不得过 0.02% / Not more than 0.02% | 未过 0.02% / Less than 0.02% |
| 铵盐 / Ammonium | 应不得过 0.02% / Not more than 0.02% | 未过 0.02% / Less than 0.02% |
| 其他氨基酸 / Other amino acids | 应不得过 0.5% / Not more than 0.5% | 未过 0.5% / Less 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 0.07% / 0.07% |
| 铁盐 / Iron | 应不得过 0.001% / Not more than 0.001% | 未过 0.001% / Less 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 / Less than 10 ppm |
| 砷盐 / Arsenic | 应不得过 0.0001% / Not more than 0.0001% | 未过 0.0001% / Less than 0.0001% |
| 热原 / Pyrogens | 应符合规定 / Should comply with regulations | 符合规定 / Complies with regulations |
| 含量测定 / Assay | 按干燥品计算，含门冬氨酸 (C4H7NO4) 应为 98.5%~101.5% / Calculated on the dried basis, contains Aspartic Acid (C4H7NO4) 98.5% to 101.5%. | 为 100.1% / 100.1% |
| 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
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