噻奈普汀钠30123-17-2质检单
化 验 报 告 单
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Product 产品名称 |
Tianeptine sodium 噻奈普汀钠 |
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Batch No. 批号 |
22072325 |
Mfg. Date 生产日期 |
2022.07.23 |
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Test Date 批准日期 |
2022.08.24 |
Exp. Date 有效期至 |
2024.07.22 |
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Tests 项目 |
Specifications 标准 |
Results 结果 |
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Description 性状 |
White to yellowish powder,very hygroscopic. 白色或淡黄色粉末，极易引湿 |
Off-white powder,very hygroscopic. 类白色粉末，极易引湿 |
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Solubility 溶解度 |
Freetly soluble In water and methanol and dichloromethane 在水、甲醇和二氯甲烷中易溶 |
Complies 符合要求 |
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Identification 鉴别 |
（1）By IR, To match with working standard IR 图谱应与对照品一致 |
Complies 符合要求 |
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（2）It gives reaction of sodium 应显钠盐的鉴别反应 |
Complies 符合要求 |
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Impurities A 杂质 A |
≤0.1% |
Not detected 未检出 |
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Related compounds 有关物质 |
Any impurity 任意杂质 ≤0.1% |
单个最大杂质 Single maximum impurity 0.07 |
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Total impurities 总杂质 ≤0.4% |
0.13% |
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Residual Solvents 溶剂残留 |
Acetidin 乙酸乙酯≤ 0.5% |
Not detected 未检出 |
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Dichloromethane 二氯甲烷≤ 0.06% |
Not detected 未检出 |
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Methanol 甲醇≤ 0.3% |
Not detected 未检出 |
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Acetone 丙酮≤ 0.5% |
Not detected 未检出 |
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Triethylamine 三乙胺≤0.032% |
Not detected 未检出 |
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Ethanol 乙醇≤0.5% |
Not detected 未检出 |
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N, N-dimethylformamide N,N-二甲基甲酰胺 ≤0.088% |
0.041% |
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Water 水分 |
≤ 5.0% |
1.69% |
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Assay 含量 |
99.0%-101.0%（On anhydrous basis 以干品计） |
99.47% |
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