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      1. 浙江金立源藥業有限公司
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         產品名稱: 西洛他唑

        基本信息

        化學名稱:6-[4-(1-環己基-1H-四氮唑-5-基)丁基]3,4-二氫喹啉-2-(1H)-酮

        結構式:

              

        分子式:C20H27N5O2

        分子量:369.46

        CAS NO.:73963-72-1

        質量標準:USP/ EP/ JP/ 國家標準, 可提供DMF/ AMF / GMP。

        Specification

         USP 38

        Items

        Acceptance criteria

        Results

        Appearance

         White to off-white crystalline powder

         White crystalline powder

        Solubility

        It is slightly soluble in methanol, in ethanol (99.5), in acetonitrile, and practically insoluble in water.

         Conforms

        Identification

         A. The IR spectrum should correspond to that obtained with RS

         Consistent with that obtained with RS

         B. The retention time of the major peak in the chromatogram of the Assay preparation should correspond to that in the chromatogram of the RS, as obtained in the Assay

         Consistent with that  obtained with Standard preparation

        Loss on Drying

         ≤0.25%

         0.07%

        Residue on Ignition

         ≤0.1%

         0.04%

        Chloride

         180 ppm

        180 ppm

        Heavy Metals

         ≤0.001%

         ≤0.001%

        Particle size

         90% less than 20um and 10% less than  10um

         Conforms

        Related Compounds

         Impurity A ≤ 0.10%

         0.02%

         Impurity B ≤ 0.10%

         Not detected

         Impurity C ≤ 0.10%

         0.03%

         Any other individual impurity ≤ 0.10%

         See Note 1

         Total impurities ≤ 0.40%

         0.21%

        Residual Solvents

         N, N-Dimethylacetamide ≤ 1090 ppm

         Conforms

         Chloroform ≤ 60 ppm

         25 ppm

         Methanol ≤ 3000ppm

         950 ppm

        Assay by HPLC

        98.0% ~ 102.0% (calculated on dried basis)

        99.8%

        Mirobiological Contarnination/g

        A) Total aerobic microbial count

        B) Total combined moulds & yeasts

        C) Other specific microorganisms(E.Coli,Salmonella sp)

         

         

        ≤1000 cfu

         

          

        ≤1000 cfu

         

        Absent

         

         

         

        Conforms

         

        Conforms

         

        Conforms

         

        Conclusion

          It complies with the requirement of USP38

         
         
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