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          浙江金立源藥業有限公司
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           產品名稱: 坎地沙坦酯

          基本信息

          化學名稱:(±)-1H-苯并咪唑-7-羧酸-2-乙氧基-1-[[2-(1H-四氮-5-基)[1,1-二苯]-4-基]甲基]-1-[[(環己基氧基)羰基]氧基]乙酯

          結構式:

                   

          分子式:C33H34N6O6

          分子量:610.67

          CAS號:145040-37-5

          質量標準:USP/ EP/ 國家標準, 可提供DMF/ CEP/ GMP。

           Specificatin

            EP 7.8

          ITEM

          CRITERIA

           RESULTES

            Appearance

             A white or almost white powder.

              White powder

            Identification-IR

            Conform to the reference spectrum

              Conforms

            Identification- UV

           Maximal absorptions at 254nm,   minimum absorption at 242nm

              Conforms

            Water

             ≤ 0.3%

               0.19%

            Residual solvents

            Methanol

             Less than 3000ppm

               N. D.

            Ethanol

             Less than 5000ppm

               N. D.

            Ethyl ether

             Less than 5000ppm

              62ppm

            Acetone

             Less than 5000ppm

              505ppm

            Ethyl acetate

             Less than 5000ppm

              N. D.

            Dichloromethane

             Less than 600ppm

              N. D.

            Dimethylformamide

             Less than 880ppm

              N. D.

            Related substances

            Impurity A

             ≤ 0.15%

              0.04%

            Impurity B

             ≤ 0.3%

              0.03%

            Impurity F

             ≤ 0.2%

              0.02%

            Impurity G

              ≤ 0.2%

              0.04%

            Impurity H

              ≤ 0.15%

              N. D.

            Other individual impurity

              ≤ 0.10%

              0.04%

            Total impurities

              ≤ 0.6%

              0.23%

            Sulfated ash

              ≤ 0.1%

              0.07%

            Heavy metals

              ≤ 10ppm

              <10ppm

          Assay (Dried substance)

              99.0~101.0%

              99.9%

            Conclusion

              Conforms to EP

           
           
           
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