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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 | 甘氨酸 Glycine | ||
| 生产日期/ Manufacturing date | 2025.04.30 | CAS No. | 56-40-6 |
| 报告日期/ Reporting date | 2025.05.09 | 批号/ Batch No. | GL396-122504302 |
| 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 Characters | 应为白色至类白色结晶性粉末；无臭。本品在水中易溶，在乙醇或乙醚中几乎不溶 White to off-white crystalline powder; odorless. Freely soluble in water, practically insoluble in ethanol or ether. | 为白色结晶性粉末；无臭。本品在水中易溶，在乙醇、乙醚中几乎不溶 White crystalline powder; odorless. Freely soluble in water, practically insoluble in ethanol or ether. |
| 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的图谱（光谱集 929 图）一致 The IR absorption spectrum should be consistent with the reference spectrum (Spectrum No. 929). | 与对照的图谱一致 Consistent with the reference spectrum. |
| 酸度 Acidity | 应为 5.6~6.6 Should be 5.6~6.6. | 为 6.1 Result is 6.1. |
| 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. | 为 99.3% Result is 99.3%. |
| 氯化物 Chlorides | 应不得过 0.007% Not more than 0.007%. | 未过 0.007% Less than 0.007%. |
| 硫酸盐 Sulfates | 应不得过 0.006% Not more than 0.006%. | 未过 0.006% Less than 0.006%. |
| 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% Less than 1 spot, less than 0.5%. |
| 干燥失重 Loss on drying | 应不得过 0.2% Not more than 0.2%. | 为 0.10% Result is 0.10%. |
| 炽灼残渣 Residue on ignition | 应不得过 0.1% Not more than 0.1%. | 为 0.06% Result is 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 20EU/g Should be less than 20 EU/g. | 小于 20EU/g Less than 20 EU/g. |
| 含量测定 Assay | 按干燥品计算，含甘氨酸 (C2H5NO2) 应为 98.5%~101.5% Calculated on the dried basis, contains Glycine (C2H5NO2) 98.5%~101.5%. | 为 100.0% Result is 100.0%. |
| 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。 Tested according to ChP 2020 Volume II, the results comply with the requirements. | |
Ningbo Inopha Biotec Ltd. | Website: www.inopha.com
Authorized Signature / Date
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