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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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