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            厄贝沙坦

            基本信息
            化学名称:
            2-丁基-3-[4-[2-(1H-四唑-5-基)苯基]苄基]-1,3-二氮杂螺-[4,4]壬-1-烯-4-酮;
            结构式:

                 

            分子式:C25H28N6O
            分子量:428.54
            CAS号:138402-11-6
            质量标准:USP/ EP/ 国家标准, GMP/ DMF 可用。

               Specification

              USP 36

                 Items

              Specification

             Test results

                 Appearance

              White to almost white crystalline powder

              White crystalline powder

                 Identification

              IR: Should comply with reference standard

               Complies

            HPLC: Should comply with reference standard

               Complies

                 Water

               NMT 0.5%

               0.15%

                 Sulphated ash

               NMT 0.2%

               NMT 0.2%

                 Heavy meatals

               NMT 0.002%

               NMT0.002%

                 Limit of Azide

               NMT 10ppm

               NMT 10ppm

                 Related compounds A

               NMT 0.2%

               0.002%

             Any other individual impurity

               NMT 0.1%

               0.004%

                 Total impurities

                (excluding R-isomer)

               NMT 0.5%

               0.15%

                Residual solvents

               Ethanol: NMT 5000 ppm

               28ppm

               Dichloromethane: NMT600 ppm

              Not detected

               D, D-dimethylformamide NMT880 ppm

              Not detected

               t-butyl methyl ether NMT5000 ppm

              Not detected

               Xylene: NMT1500ppm

               320ppm

               Toluene: NMT890ppm

               Not detected

                 Assay (HPLC)

               98.0~102.0%

               99.9%

                 Conclusion

               It Complies with USP36

             作用与用途: 抗高血压,用于治疗高血压病
             
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