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            替米沙坦

            基本信息
            化学名称: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]联苯基-2-羧酸
            分子式:C33H30N4O2
            分子量: 514.62
            CAS NO:144701-48-4
            质量标准:USP/ EP/ 国家标准, 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

            作用与用途:用于原发性高血压的治疗。

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