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              替米沙坦

              基本信息
              化學名稱:4′-[4-甲基-6-(1-甲基-1H-苯并咪唑-2-基)-2-丙基-1H-苯并咪唑基甲基]聯苯基-2-羧酸
              分子式:C33H30N4O2
              分子量: 514.62
              CAS NO:144701-48-4
              質量標準:USP/ EP/ 國家標準, 可提供DMF/ CEP/ GMP。


               Specification

                   According to European Pharmacopoeia 7.8

              Items

              Specification

              Results

              Appearance

              White or slightly yellowish crystalline powder

              White crystalline powder

              Solubility

              Should meet the requirement

              Conforms

              IR Identification

              Should correspond to the RS Infrared Absorption

              Correspond to the reference substance

              Appearance of solution

              Should meet the requirement

              Conforms

              Related substance

              Impurity A

              ≤0.15%

              0.05%

              Impurity B

              ≤0.15%

              0.02%

              Impurity C

              ≤0.2%

              0.03%

              Impurity D

              ≤0.2%

              0.05%

              Unspecified Ims.

              ≤0.1%

              0.06%

              Total

              ≤1.0%

              0.30%

              Residual solvents

              Methanol

              ≤0.3%

              Not detected

              Ethanol

              ≤0.5%

              0.031%

              Methylene dichloride

              ≤0.06%

              Not detected

              n-hexane

              ≤0.029%

              Not detected

              Acetic acid ethyl ester

              ≤0.5%

              Not detected

              Toluene

              ≤0.089%

              0.025%

              Acetic acid

              ≤0.5%

              0.036%

              Loss on drying

              ≤0.5%

              0.20%

              Sulphated ash

              ≤0.1%

              Conforms

              Melting point

                  261 ºC -263 ºC

                   261.1 ºC -262.2 ºC

              Particle size

                  90% Less than 200um

                   Conforms

              Assay

                  99.0%~101.0%

                   99.9%

              Conclusion

                 It conforms to European Pharmacopoeia 7.0

              作用與用途:用于原發性高血壓的治療。

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