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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 | 丝氨酸 L-Serine | ||
| 生产日期/ Manufacturing date | 2025.06.14 | CAS No. | 56-45-1 |
| 报告日期/ Reporting date | 2025.06.17 | 批号/ Batch No. | SE390-162506141 |
| 有效期/ Expiry date | 2027.06.13 | 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。本品在水中易溶，在乙醇、丙酮或乙醚中几乎不溶。 Should be white crystals or crystalline powder; odorless. Freely soluble in water, practically insoluble in ethanol, acetone or ether. | 为白色结晶性粉末；无臭。本品在水中易溶，在乙醇、丙酮或乙醚中几乎不溶。 White crystalline powder; odorless. Freely soluble in water, practically insoluble in ethanol, acetone or ether. |
| 比旋度 Specific Rotation | 应为 +14.0° ~ +15.6° Should be +14.0° to +15.6° | 为 +14.9° +14.9° |
| 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 those of the principal spot 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 917 图）一致 The infrared absorption spectrum should be consistent with the reference spectrum (Spectrum No. 917). | 与对照的图谱一致 Consistent with the reference spectrum. |
| 酸度 Acidity | 应为 5.5 ~ 6.5 Should be 5.5 to 6.5 | 为 5.8 5.8 |
| 溶液的透光率 Transmittance of solution | 在 430nm 的波长处应不低于 98.0% Not less than 98.0% at 430nm wavelength | 为 98.9% 98.9% |
| 氯化物 Chlorides | 应不得过 0.02% Not more than 0.02% | 未过 0.02% Not more than 0.02% |
| 硫酸盐 Sulfates | 应不得过 0.02% Not more than 0.02% | 未过 0.02% Not more than 0.02% |
| 铵盐 Ammonium salts | 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 | 应不得过 0.5% Not more than 0.5% | 未过 0.5% Not more than 0.5% |
| 干燥失重 Loss on drying | 应不得过 0.2% Not more than 0.2% | 为 0.10% 0.10% |
| 炽灼残渣 Residue on ignition | 应不得过 0.1% Not more than 0.1% | 为 0.08% 0.08% |
| 铁盐 Iron salts | 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 salts | 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 12EU/g Less than 12 EU/g | 小于 12EU/g Less than 12 EU/g |
| 含量 Assay | 按干燥品计算，含丝氨酸 (C3H7NO3) 不得少于 98.5% Calculated on the dried basis, the content of Serine (C3H7NO3) should be not less than 98.5% | 为 99.6% 99.6% |
| 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。 This product was tested according to the Chinese Pharmacopoeia 2020 Edition Volume II, and the results comply with the regulations. | |
Ningbo Inopha Biotec Ltd. | Website: www.inopha.com
Authorized Signature / Date
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