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品名Product:二氟尼柳 Diflunisal |
報告書編號C/A No: |
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檢品數(shù)量Test Substance Quantity:1KG |
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批號Batch No:20200418 |
生產日期Manufacture Date:2020.04.18 |
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凈重Net Weight:25kg/Fiber drum |
化驗日期Analysis Date:2020.04.18 |
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執(zhí)行標準As per Standard:美國藥典34版USP34 |
有效期至Expiration date:2022.04.17 |
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檢驗項目Items Tested |
標準要求Specification |
檢驗結果Results |
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性狀 Characters |
白色結晶性粉末或無色結晶 White,crystalline powder or colorless crystals |
白色粉末 White Powder |
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鑒別 Identification |
呈正反應 Positive |
呈正反應 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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重金屬 Heavy metals |
≤0.001% |
＜0.001 |
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有關物質 related substances |
符合規(guī)定 Comply with the requirement |
符合規(guī)定 Comply with the requirement |
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灼燒殘渣 residue on ignition |
≤0.1 |
0.05 |
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有機殘留量 organic volatile impurities |
符合規(guī)定 Comply with the requirement |
符合規(guī)定 Comply with the requirement |
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溶液色澤 appearance of solution |
符合規(guī)定 Comply with the requirement |
符合規(guī)定 Comply with the requirement |
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色譜純度 chromatographic purity |
符合規(guī)定 Comply with the requirement |
符合規(guī)定 Comply with the requirement |
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檢驗結論：符合USP 34標準規(guī)定 Conclusion: Comply with the requirement of standard for USP34 |
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