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分析单
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品名Product:二氟尼柳 Diflunisal |
报告书编号C/A No: |
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检品数量Test Substance Quantity:1KG |
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批号Batch No:20200418 |
生产日期Manufacture Date:2020.04.18 |
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净重Net Weight:25kg/Fiber drum |
化验日期Analysis Date:2020.04.18 |
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执行标准As per Standard:美国药典34版USP34 |
有效期至Expiration date:2022.04.17 |
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检验项目Items Tested |
标准要求Specification |
检验结果Results |
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性状 Characters |
白色结晶性粉末或无色结晶 White,crystalline powder or colorless crystals |
白色粉末 White Powder |
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鉴别 Identification |
呈正反应 Positive |
呈正反应 Positive |
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含量 Assay |
98.0--101.5% |
99.61% |
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干燥失重 Loss on drying |
≤3.0% |
0.06% |
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重金属 Heavy metals |
≤0.001% |
＜0.001 |
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有关物质 related substances |
符合规定 Comply with the requirement |
符合规定 Comply with the requirement |
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灼烧残渣 residue on ignition |
≤0.1 |
0.05 |
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有机残留量 organic volatile impurities |
符合规定 Comply with the requirement |
符合规定 Comply with the requirement |
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溶液色泽 appearance of solution |
符合规定 Comply with the requirement |
符合规定 Comply with the requirement |
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色谱纯度 chromatographic purity |
符合规定 Comply with the requirement |
符合规定 Comply with the requirement |
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检验结论：符合USP 34标准规定 Conclusion: Comply with the requirement of standard for USP34 |
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