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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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