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      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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