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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 | 甲硫氨酸 Methionine | ||
| 生产日期/ Manufacturing date | 2025.06.01 | CAS No. | 63-68-3 |
| 报告日期/ Reporting date | 2025.06.08 | 批号/ Batch No. | ME198-112506011 |
| 有效期/ Expiry date | 2027.05.31 | 重量/ Quantity | |
| 检测项目 / Item | 检测标准 / Standard | 检测结果 / Result |
|---|---|---|
| 性状 Appearance | 应为白色或类白色结晶或结晶性粉末；有特臭。本品在水中溶解，在乙醇中几乎不溶，在乙醚中不溶；在稀盐酸或氢氧化钠溶液中易溶。 Should be white or almost white crystals or crystalline powder; with a characteristic odor. Soluble in water, practically insoluble in ethanol, insoluble in ether; easily soluble in dilute hydrochloric acid or sodium hydroxide solution. | 为白色结晶性粉末；有特臭。本品在水中溶解，在乙醇中几乎不溶，在乙醚中不溶；在稀盐酸、氢氧化钠溶液中易溶。 White crystalline powder; with a characteristic odor. Soluble in water, practically insoluble in ethanol, insoluble in ether; easily soluble in dilute hydrochloric acid or sodium hydroxide solution. |
| 比旋度 Specific Rotation | 应为 +21.0° ~ +25.0° Should be +21.0° ~ +25.0° | 为 +23.1° +23.1° |
| 鉴别 (1) 化学鉴别 Identification (1) Chemical Identification | 应呈正反应 Should show positive reaction | 呈正结果 Positive result |
| 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 1045 图）一致 The IR absorption spectrum should be consistent with the reference spectrum (Spectrum Set 1045) | 与对照的图谱一致 Consistent with the reference spectrum |
| 酸度 Acidity | 应为 5.6 ~ 6.1 Should be 5.6 ~ 6.1 | 为 5.8 5.8 |
| 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 99.5% 99.5% |
| 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 0.13% 0.13% |
| 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 0.0015% Not more than 0.0015% | 未过 0.0015% Not more than 0.0015% |
| 重金属 Heavy metals | 应不得过百万分之十 Not more than 10ppm | 未过百万分之十 Not more than 10ppm |
| 砷盐 Arsenic | 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 25EU/g Less than 25EU/g | 小于 25EU/g Less than 25EU/g |
| 含量测定 Assay | 按干燥品计算，含甲硫氨酸 (C5H11NO2S) 不得少于 98.5% Calculated on the dried basis, contains not less than 98.5% of Methionine (C5H11NO2S) | 为 100.4% 100.4% |
| 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
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