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              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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