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  • 當前位置:產品與服務 >西洛他唑
    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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