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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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