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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 | 盐酸赖氨酸 L-Lysine Hydrochloride | ||
| 生产日期/ Manufacturing date | 2025.04.30 | CAS No. | |
| 报告日期/ Reporting date | 2025.05.14 | 批号/ Batch No. | 042504301 |
| 有效期/ Expiry date | 2027.04.29 | 重量/ Quantity | |
| 检测项目 / Item | 检测标准 / Standard | 检测结果 / Result |
|---|---|---|
| 性状 Description | 应为白色结晶或结晶性粉末；无臭。本品在水中易溶，在乙醇中极微溶解，在乙醚中几乎不溶。 White crystals or crystalline powder; odorless. Freely soluble in water, very slightly soluble in ethanol, practically insoluble in ether. | 为白色结晶性粉末；无臭。本品在水中易溶，在乙醇中极微溶解，在乙醚中几乎不溶。 White crystalline powder; odorless. Freely soluble in water, very slightly soluble in ethanol, practically insoluble in ether. |
| 比旋度 Specific rotation | +20.4° ～ +21.5° | +20.9° |
| 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 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品的图谱一致 The infrared absorption spectrum should be consistent with the reference spectrum. | 与对照品的图谱一致 Consistent with the reference spectrum. |
| 鉴别 (3) 化学鉴别 Identification (3) Chemical identification | 应呈正反应 Should show positive reaction. | 呈正反应 Positive reaction. |
| 酸度 Acidity | 5.0～6.0 | 5.4 |
| 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. | 99.6% |
| 硫酸盐 Sulfate | 不得过 0.02% Not more than 0.02% | 未过 0.02% Not more than 0.02% |
| 铵盐 Ammonium | 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 | 不得过 0.5% Not more than 0.5% | 未过 0.5% Not more than 0.5% |
| 干燥失重 Loss on drying | 不得过 0.4% Not more than 0.4% | 0.11% |
| 炽灼残渣 Residue on ignition | 不得过 0.1% Not more than 0.1% | 0.07% |
| 铁盐 Iron | 不得过 0.003% Not more than 0.003% | 未过 0.003% Not more than 0.003% |
| 重金属 Heavy metals | 不得过百万分之十 Not more than 10ppm | 未过百万分之十 Not more than 10ppm |
| 砷盐 Arsenic | 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 10EU/g Less than 10EU/g | 小于 10EU/g Less than 10EU/g |
| 含氯量 Chloride content | 19.0% ～ 19.6% | 19.4% |
| 含量测定 Assay | 按干燥品计算，含盐酸赖氨酸不得少于 98.5% Calculated on the dried basis, contains not less than 98.5% of L-Lysine Hydrochloride. | 100.3% |
| 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 Volume II, and the results comply with the requirements. | |
Ningbo Inopha Biotec Ltd. | Website: www.inopha.com
Authorized Signature / Date
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