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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 | L-谷氨酰胺 L-Glutamine | ||
| 生产日期/ Manufacturing date | 2026.02.12 | CAS No. | 56-85-9 |
| 报告日期/ Reporting date | 2026.04.08 | 批号/ Batch No. | GL645-202602902 |
| 有效期/ Expiry date | 2028.02.11 | 重量/ Quantity | |
| 检测项目 / Item | 检测标准 / Standard | 检测结果 / Result |
|---|---|---|
| 性状 Description | 白色结晶或结晶性粉末；无臭。本品在水中溶解，在乙醇或乙醚中几乎不溶。 White crystals or crystalline powder, odorless. This product is soluble in water, almost insoluble in ethanol or ether | 符合规定 Conforms |
| 鉴别 Identification (1) | 取本品的水溶液（1→50）5ml,加稀盐酸5滴与亚硝酸钠试液1ml,应发泡； Take 5ml of aqueous solution (1→50) of this product, add 5 drops of diluted hydrochloric acid and 1ml of sodium nitrite test solution, and it should be foaming; | 符合规定 Conforms |
| 鉴别 Identification (2) | 取本品的水溶液（1→1000）5ml，加茚三酮试液1ml，加热3分钟，溶液显紫色. Take 5ml of water solution (1→1000) of this product, add 1ml of ninhydrin test solution, heat for 3 minutes, the solution will appear purple | 符合规定 Conforms |
| 鉴别 Identification (IR) | 本品的红外光吸收图谱应与对照的图谱（光谱集895）一致。 Compare the infrared absorption spectrum of the sample with that of the standard atlas 895. | 一致 Identical |
| 鉴别 Identification (HPLC) | 供试品溶液主峰的保留时间应与对照品溶液主峰的保留时间一致。 The retention time of the major peak in the test solution should match with that of the standard solution. | 一致 Identical |
| 比旋度 Specific optical rotation [α]D20 | +6.3° ～ +7.3° | +6.7° |
| 酸度 pH | 4.8 ～ 5.8 | 4.8 |
| 透光率 Transmittance | ≥98.0% | 99.8% |
| 氯化物 Chloride | ≤0.02% | ＜0.02% |
| 硫酸盐 Sulfate | ≤0.02% | ＜0.02% |
| 铁盐 Iron | ≤0.001% | ＜0.001% |
| 铵盐 Ammonium | ≤0.10% | ＜0.10% |
| 重金属 Heavy metals | ≤0.001% | ＜0.001% |
| 砷盐 Arsenic | ≤1ppm | ＜1ppm |
| 干燥失重 Loss on Drying | ≤0.30% | 0.1% |
| 炽灼残渣 Residue on ignition | ≤0.1% | 0.05% |
| 有关物质 Related substances - 焦谷氨酸 Pyroglutamic acid | ≤0.5% | ＜0.5% |
| 有关物质 Related substances - 谷氨酸 Glutamate | ≤0.5% | ＜0.5% |
| 有关物质 Related substances - 单个杂质 Single impurity | ≤0.5% | ＜0.5% |
| 有关物质 Related substances - 其他总杂质 Total impurity | ≤1.0% | ＜1.0% |
| 含量 Assay | 99.0% ～ 101.0% | 99.7% |
| 微生物限度 Microbiological examination - 需氧菌总数 Total aerobic microbial count | ≤50cfu/g | ＜50cfu/g |
| 微生物限度 Microbiological examination - 霉菌和酵母菌总数 Total yeasts and moulds count | ≤10cfu/g | ＜10cfu/g |
| 细菌内毒素 Endotoxin | ＜6EU/g | ＜6EU/g |
| 检测结论/ Conclusion | 本品按企业标准检验，结果符合规定。 Conclusion: After test, the product is complied with in house standards. | |
Ningbo Inopha Biotec Ltd. | Website: www.inopha.com
Authorized Signature / Date
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