COA 质检单预览
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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-丙氨酰-L-谷氨酰胺 / L-Alanyl-L-Glutamine | ||
| 生产日期/ Manufacturing date | 2025.06.20 | CAS No. | 39537-23-0 |
| 报告日期/ Reporting date | 2025.07.02 | 批号/ Batch No. | AL808-202506101 |
| 有效期/ Expiry date | 2027.06.19 | 重量/ Quantity | |
| 检测项目 / Item | 检测标准 / Standard | 检测结果 / Result |
|---|---|---|
| 性状 / Description | 本品为白色或类白色结晶或结晶性粉末;无臭。本品在水中易溶，在乙醇、丙酮或乙醚中不溶。 / This product is white or white crystal or crystalline powder; Odorless. This product is soluble in water and insoluble in ethanol, acetone or ether. | 符合规定 / conforms |
| 鉴别 (1) / Identification (1) | 取本品约 20mg，加水 lml 使溶解，加茚三酮试液 5 滴 ，加热，即显蓝紫色。 / Take about 20mg of this product, add lml of water to dissolve it, add 5 drops of ninhydrin test solution, heat it to make it appear bluish purple. | 符合规定 / conforms |
| 鉴别 (2) / Identification (2) | 本品的红外光吸收图谱应与对照品的图谱一致。 / The infrared absorption pattern of this product should be consistent with that of the reference product. | 符合规定 / conforms |
| 鉴别 (3) / Identification (3) | 在含量测定项下记录的色谱图中，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。 / In the chromatogram recorded under content determination, the retention time of the main peak of the test solution should be consistent with that of the control solution. | 符合规定 / conforms |
| 比旋度 / Specific rotation [α]D20 | +9.5 to +11.0° | +10.7° |
| 溶液的澄清度与颜色 / Clarity and color of the solution | 溶液应澄清无色，如显浑浊，与 1 号浊度标准液比较，不得更浓；如显色，与黄色 1 号标准比色液比较，不得更深。 / The solution should be clear and colorless, such as turbidity, and no. 1 turbidity standard solution compared, not thicker; If the color is displayed, it shall not be darker than yellow 1 standard colorimetric solution. | 符合规定 / Conforms |
| 氯化物 / Chloride | ≤0.02 % | <0.02 % |
| 硫酸盐 / Sulfate | ≤0.02 % | <0.02 % |
| 铵盐 / Ammonium | ≤0.08 % | <0.08 % |
| 铁盐 / Iron | ≤0.001% | <0.001% |
| 重金属 / Heavy metals | ≤0.001% | <0.001% |
| 砷 / Arsenic | ≤0.0001% | <0.0001% |
| 有关物质 / Related Compounds | 环-(L-丙氨酰-L-谷氨酰胺）≤0.2%, 环-(L-丙氨酰-L-谷氨酸）≤0.04%, L-焦谷氨酰-L-丙氨酸 ≤0.15%, L-焦谷氨酸 ≤0.05%, D-丙氨酰-L-谷氨酰胺 ≤0.05%, L-丙氨酰 -L-谷氨酸 ≤0.5%, 其他单个未知杂质 ≤0.1%, 其他未知杂质总和 ≤0.5% / Cyclo(L-Alanyl-L-Glutamine) ≤0.2%, Cyclo(L-Alanyl-L-Glutamic acid) ≤0.04%, L-Pyroglutamyl-L-Alanine ≤0.15%, L-Pyroglutamic acid ≤0.05%, D-Alanyl-L-Glutamine ≤0.05%, L-Alanyl-L-Glutamic acid ≤0.5%, Other individual unknown impurity ≤0.1%, Total other unknown impurities ≤0.5% | 符合规定 / conforms |
| 干燥失重 / Loss on Drying | ≤0.5 % | 0.1% |
| 灼烧残渣 / Residue on ignition | ≤0.1 % | 0.07% |
| 含量 / Assay | 98.5~101.0% | 99.8% |
| 酸度 / pH | 5.4 ~ 6.0 | 5.6 |
| 需氧菌总数 / Total aerobic microbial count | ≤50cfu/g | ＜10cfu/g |
| 霉菌和酵母菌总数 / Total yeasts and moulds count | ≤10cfu/g | ＜10cfu/g |
| 细菌内毒素 / Endotoxin | ≤20 EU/g | ＜20 EU/g |
| 检测结论/ Conclusion | 符合客户标准要求 / Agree with the specification of Customer standards. | |
Ningbo Inopha Biotec Ltd. | Website: www.inopha.com
Authorized Signature / Date
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