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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 | 苏氨酸 L-Threonine | ||
| 生产日期/ Manufacturing date | 2025.06.10 | CAS No. | |
| 报告日期/ Reporting date | 2025.06.13 | 批号/ Batch No. | 032506102 |
| 有效期/ Expiry date | 2027.06.09 | 重量/ Quantity | |
| 检测项目 / Item | 检测标准 / Standard | 检测结果 / Result |
|---|---|---|
| 性状 Appearance | 应为白色结晶或结晶性粉末；无臭。本品在水中溶解，在乙醇中几乎不溶 / Should be white crystals or crystalline powder; odorless. Soluble in water, practically insoluble in ethanol. | 为白色结晶性粉末；无臭。本品在水中溶解，在乙醇中几乎不溶 / White crystalline powder; odorless. Soluble in water, practically insoluble in ethanol. |
| 比旋度 Specific Rotation | 应为 -26.0° ~ -29.0° / Should be -26.0° to -29.0° | 为 -28.1° / -28.1° |
| 鉴别 (1) 化学鉴别 Identification (1) Chemical Identification | 应呈正反应 / Should show positive reaction | 呈正反应 / Positive |
| 鉴别 (2) 薄层色谱 Identification (2) 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 (3) 红外光谱 Identification (3) IR | 红外光吸收图谱应与对照的图谱（光谱集 957 图）一致 / The IR absorption spectrum should be consistent with the reference spectrum (Spectrum No. 957) | 与对照的图谱一致 / Consistent with the reference spectrum |
| 酸度 Acidity | 应为 5.0 ~ 6.5 / Should be 5.0 to 6.5 | 为 5.6 / 5.6 |
| 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 99.1% / 99.1% |
| 氯化物 Chloride | 应不得过 0.02% / Not more than 0.02% | 未过 0.02% / Less than 0.02% |
| 硫酸盐 Sulfate | 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%，且不得超过 1 个 / Not more than 0.5%, and not more than 1 spot | 未过 0.5%，未过 1 个 / Less than 0.5%, less than 1 spot |
| 干燥失重 Loss on drying | 应不得过 0.2% / Not more than 0.2% | 为 0.10% / 0.10% |
| 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% / 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% |
| 细菌内毒素 Bacterial endotoxins | 应小于 12EU/g / Less than 12EU/g | 小于 12EU/g / Less than 12EU/g |
| 含量测定 Assay | 按干燥品计算，含苏氨酸 (C4H9NO3) 不得少于 98.5% / Calculated on the dried basis, contains not less than 98.5% of Threonine (C4H9NO3) | 为 99.7% / 99.7% |
| 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
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