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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 | 谷氨酸 Glutamic Acid | ||
| 生产日期/ Manufacturing date | 2025.01.07 | CAS No. | 56-86-0 |
| 报告日期/ Reporting date | 2025.01.24 | 批号/ Batch No. | 102501072 |
| 有效期/ Expiry date | 2027.01.06 | 重量/ Quantity | |
| 检测项目 / Item | 检测标准 / Standard | 检测结果 / Result |
|---|---|---|
| 性状 Characters | 应为白色结晶或结晶性粉末；本品在热水中溶解，在水中微溶，在乙醇、丙酮或乙醚中不溶，在稀盐酸或1mol/L 氢氧化钠溶液中易溶。 White crystals or crystalline powder; soluble in hot water, slightly soluble in water, insoluble in ethanol, acetone or ether, easily soluble in dilute hydrochloric acid or 1mol/L sodium hydroxide solution. | 为白色结晶性粉末；本品在热水中溶解，在水中微溶，在乙醇、丙酮、乙醚中不溶，在稀盐酸、1mol/L 氢氧化钠溶液中易溶。 White crystalline powder; soluble in hot water, slightly soluble in water, insoluble in ethanol, acetone or ether, easily soluble in dilute hydrochloric acid or 1mol/L sodium hydroxide solution. |
| 比旋度 Specific Rotation | 应为+31.5° ～ +32.5° Should be +31.5° to +32.5° | 为+31.7° +31.7° |
| 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 main spot of the test solution should be the same as that of the reference solution. | 与对照品溶液的主斑点相同 Same as the main 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 958 图）一致 The infrared absorption spectrum should be consistent with the reference spectrum (Spectrum No. 958). | 与对照的图谱一致 Consistent with the reference spectrum |
| 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 wavelength. | 为 99.4% 99.4% |
| 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 0.5% Not more than 0.5% | 为 0.09% 0.09% |
| 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 0.0005% Not more than 0.0005% | 未过 0.0005% Not more than 0.0005% |
| 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% |
| 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，含谷氨酸 (C5H9NO4) 不得少于 98.5% Calculated on the dried basis, contains not less than 98.5% of Glutamic Acid (C5H9NO4). | 为 100.3% 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。 This product was tested according to the Chinese Pharmacopoeia 2020 Edition Volume II, and the results comply with the requirements. | |
Ningbo Inopha Biotec Ltd. | Website: www.inopha.com
Authorized Signature / Date
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