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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-天冬酰胺一水合物 L-Asparagine Monohydrate | ||
| 生产日期/ Manufacturing date | 2025.05.13 | CAS No. | |
| 报告日期/ Reporting date | 2026.02.05 | 批号/ Batch No. | 202505903 |
| 有效期/ Expiry date | 2027.05.12 | 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。本品在热水中易溶，在甲醇、乙醇或乙醚中几乎不溶；在稀盐酸或氢氧化钠试液中易溶。 This product is white or white crystal or crystalline powder; Odorless. It is easily soluble in hot water and almost insoluble in methanol, ethanol or ether. Soluble in dilute hydrochloric acid or sodium hydroxide test solution. | 符合规定 Conforms |
| 鉴别 (1) Identification (1) | 取本品约1g，加10%氢氧化钠溶液5ml，微热至沸，产生的蒸汽有氨臭并能使湿润的红色石蕊试纸变蓝色。 Take about 1g of this product, add 5ml of 10% sodium hydroxide solution, heat slightly to boiling, the generated steam has ammonia odor, and can turn the wet red litmus test paper blue. | 一致 Identical |
| 鉴别 (2) Identification (2) | 取本品约1mg，加水5ml溶解后，加茚三酮5mg，加热，溶液显紫色。 Take about 1mg of this product, dissolve it with 5ml of water, add 5mg of ninhydrin, and heat the solution to show purple. | 一致 Identical |
| 比旋度 Specific optical rotation [α]D20 | + 31° ～ + 35° | +34.3° |
| 透光率 Transmittance | ≥98.0% | 99.8% |
| 氯化物 Chloride | ≤0.005% | ＜0.005% |
| 硫酸盐 Sulfate | ≤0.005% | ＜0.005% |
| 铁盐 Iron | ≤0.001% | ＜0.001% |
| 铵盐 Ammonium | ≤0.1% | ＜0.1% |
| 重金属 Heavy metals | ≤0.001% | ＜0.001% |
| 砷盐 Arsenic | ≤0.0001% | ＜0.0001% |
| 干燥失重 Loss on Drying | 11.5% ～ 12.5% | 12.0% |
| 炽灼残渣 Residue on ignition | ≤0.1% | 0.05% |
| 相关物质 (天冬氨酸) Related substances (Aspartic acid) | ≤0.5% | ＜0.5% |
| 相关物质 (总杂) Related substances (Sum of Impurities) | ≤0.8% | ＜0.8% |
| 含量 Assay | 98.0% ～ 101.0% | 99.7% |
| 微生物限度 (需氧菌总数) Microbiological examination (Total aerobic microbial count) | ≤50cfu/g | ＜50cfu/g |
| 微生物限度 (霉菌和酵母菌总数) Microbiological examination (Total yeasts and moulds count) | ≤10cfu/g | ＜10cfu/g |
| 细菌内毒素 Endotoxin | ＜6 EU/g | ＜6 EU/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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