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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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