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          浙江金立源藥業有限公司
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           產品名稱: 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

          結構式:
                

          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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