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            西洛他唑

            基本信息
            化学名称:6-[4-(1-环己基-1H-四氮唑-5-基)丁基]3,4-二氢喹啉-2-(1H)-酮
            结构式:

                  

            分子式:C20H27N5O2
            分子量:369.46
            CAS NO.:73963-72-1
            质量标准:USP/ EP/ JP/ 国家标准, 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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