Hunan Flag Bio-technology Co.,Ltd.
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检验项目
Item
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检验标准
Inspection Standard
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检验结果
Results
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外观Appearance
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White or almost white crystalline powder,
白色或类白色结晶粉末
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Conforms
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鉴别 Identification
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Enterprise Standard 企业标准
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Conforms
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有关物质 Related Substance
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Lithocholic Acid ≤0.1%
胆石酸 ≤0.1%
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Conforms
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比旋度Specific Optical Rotation
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+58 - +62°
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+60.0°
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熔点 Melting Piont
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200℃ -204℃
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201.3℃-202.6℃
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干燥失重 Loss on drying
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≤1.0%
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0.6 %
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灼烧残渣 Ignition residue
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≤0.1%
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0.08%
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含量 Assay
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≥ 99.0%—101.0%
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100.8%
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重金属 Heavy Mental
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≤ 10ppm
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Conforms
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液相纯度
Purity HPLC
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CDCA ≤1.0%
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0.22%
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Max. each impurity ≤0.1%
总杂
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0.095%
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Total Impurity ≤1.5%
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0.44%
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结论:本品经检验,各项指标均符合企业标准。
Conclusion: The product Conforms to the standard.
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