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 | N-乙酰-L-半胱氨酸 N-Acetyl-L-Cysteine | ||
| 生产日期/ Manufacturing date | 2023.10.30 | CAS No. | |
| 报告日期/ Reporting date | 2023.12.29 | 批号/ Batch No. | C103-202310022 |
| 有效期/ Expiry date | 2026.10.20 | 重量/ Quantity | |
| 检测项目 / Item | 检测标准 / Standard | 检测结果 / Result |
|---|---|---|
| 性状 Description | 白色或类白色结晶性粉末，有类似蒜的臭气；有引湿性。本品在水或乙醇中易溶。White or almost white, crystalline powder; garlic smell; easily imbibe. Freely soluble in water or ethanol. | 白色结晶性粉末，溶解性符合规定 White crystalline powder Solubility conforms |
| 熔点 Melting point | 104℃~110℃ | 107~109℃ |
| 比旋度[α]D20 Specific optical rotation[α]D20 | +21.0° ~ +27.0° | +25.1° |
| 鉴别 Identification | (1) 本品约 0.1g, 加 10%氢氧化钠溶液 2ml 溶解后, 加醋酸铅试液 1ml, 加热煮沸, 溶液渐显黄褐色, 继而产生黑色沉淀。It reacts with lead acetate test solution to give a yellow-brown color, then black precipitate. (2) 取本品约 10mg, 加氢氧化钠试液 1ml 溶解后, 加亚硝基铁氰化钠试液数滴, 摇匀, 即显深红色; 放置后渐显黄色, 上层留有红色环, 振摇后又变成红色。It reacts with sodium nitroprusside to give a red color, after a while, change into yellow, with red link remaining in the surface layer, when shaking it turns into red again. (3) 本品的红外光吸收图谱应与对照的图谱（光谱集 7 图）一致。Compare the infrared absorption spectrum of the sample with that of the standard atlas 7. | 黑色沉淀 Black precipitate; 符合规定 Conforms; 一致 Identical |
| 酸度 pH | 1.5 ~ 2.5 | 2.0 |
| 溶液的澄清度（透光率） Clarity of solution (Transmittance) | 溶液澄清 Clear 透光率 Transmittance ≥98.0% | 溶液澄清 Clear 99.5% |
| 氯化物 Chloride | ≤0.04% | <0.04% |
| 干燥失重 Loss on drying | ≤1.0% | 0.1% |
| 炽灼残渣 Residue on ignition | ≤0.1% | 0.06% |
| 重金属 Heavy metals | ≤0.001% | <0.001% |
| 含量 Assay | 98.0% ~ 102.0% | 100.4% |
| 有关物质 Related substances (最大单个杂质 Maximum impurity) | 最大单个杂质 Maximum impurity ≤0.5% | 0.04% |
| 有关物质 Related substances (总有关物质 Total impurities) | 总有关物质 Total impurities ≤1.0% | 0.06% |
| 微生物限度 Microbiological examination (需氧菌总数 Total aerobic microbial count) | 需氧菌总数 Total aerobic microbial count ≤1000cfu/g | <10cfu/g |
| 微生物限度 Microbiological examination (霉菌和酵母菌总数 Mould and yeasts) | 霉菌和酵母菌总数 Mould and yeasts ≤100cfu/g | <10cfu/g |
| 检测结论/ Conclusion | 结论：本品按客户质量标准检验，结果符合规定。Conclusion: Agree with the customer standards. | |
Ningbo Inopha Biotec Ltd. | Website: www.inopha.com
Authorized Signature / Date
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