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      浙江金立源藥業有限公司
      重點產品:
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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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