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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-半胱氨酸盐酸盐一水合物 L-Cysteine Hydrochloride Monohydrate | ||
| 生产日期/ Manufacturing date | 2026.03.08 | CAS No. | 7048-04-6 |
| 报告日期/ Reporting date | 2026.05.06 | 批号/ Batch No. | CY153-202603903 |
| 有效期/ Expiry date | 2028.03.07 | 重量/ Quantity | |
| 检测项目 / Item | 检测标准 / Standard | 检测结果 / Result |
|---|---|---|
| 性状 Description | 白色或类白色结晶或结晶性粉末；有臭。本品在水中易溶，在乙醇中略溶，在丙酮中几乎不溶。 White or off-white crystals or crystalline powders; Stinky. This product is soluble in water, slightly soluble in ethanol, and almost insoluble in acetone. | 符合规定 Conforms |
| 鉴别 (1) Identification (1) | 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 principal spot in the chromatogram obtained with the test solution is similar in position and color to the principal spot in the chromatogram obtained with the reference solution. | 一致 Identical |
| 鉴别 (2) Identification (2) | 本品的红外光吸收图谱应与对照的图谱（光谱集816）一致。 Compare the infrared absorption spectrum of the sample with that of the standard atlas 816. | 一致 Identical |
| 比旋度 Specific optical rotation [α]D20 | +5.5° ～ +7.0° | +6.3° |
| 酸度 pH | 1.5 ～ 2.0 | 1.8 |
| 透光率 Transmittance | ≥98.0% | 99.8% |
| 含氯量 Chloride | 19.8% ～ 20.8% | 20.1% |
| 硫酸盐 Sulfate | ≤0.02% | ＜0.02% |
| 铁盐 Iron | ≤0.001% | ＜0.001% |
| 重金属 Heavy metals | ≤0.001% | ＜0.001% |
| 砷盐 Arsenic | ≤0.0001% | ＜0.0001% |
| 干燥失重 Loss on Drying | 8.0% ～ 12.0% | 10.4% |
| 炽灼残渣 Residue on ignition | ≤0.1% | 0.06% |
| 其他氨基酸 Other amino acids | ≤0.5% | ＜0.5% |
| 含量 Assay | 98.5% ～ 101.0% | 100.2% |
| 微生物限度 (需氧菌总数) Microbiological examination (Total aerobic microbial count) | ≤50cfu/g | ＜10cfu/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 | ＜12EU/g | ＜12EU/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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