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为建立丁酸氯维地平药物的仿制提供了杂质标准品,对其4个特定杂质进行合。以2,3-二氯苯甲醛、乙酰乙酸(2-氰基)乙酯、3-氨基巴豆酸甲酯、乙酰乙酸甲酯和三羟基丙腈为主要试剂,制备了丁酸氯维地平4个杂质:4-(2,3-二氯苯基)-2,6-二甲基-1,4-二氢吡啶-3,5-二羧酸单甲酯,6-(2,3-二氯苯基)-2-甲基-4-氧代环己烯-2-甲酸甲酯,6-(2,3-二氯苯基)-4-甲基-2-氧代环己烯-3-甲酸甲酯,4-(2,3-二氯苯基)-2,6-二甲基-1,4-二氢吡啶-3,5-二羧酸甲基酯。所合成的杂质结构经NMR和MS确证,杂质的含量达到98%。
Impurity standards were provided for the establishment of generic versions of clevidipine butyrate drugs, combining four of their specific impurities. Chlorvodipropionate 4 was prepared with 2,3-dichlorobenzaldehyde, (2-cyano) ethyl acetoacetate, methyl 3-aminocrotonate, methyl acetoacetate and trihydroxypropionitrile as the main reagents Impurity: 4- (2,3-dichlorophenyl) -2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic acid monomethyl ester, 6- (2,3- Dichlorophenyl) -2-methyl-4-oxocyclohexene-2-carboxylate, methyl 6- (2,3- dichlorophenyl) Carboxylate, methyl 4- (2,3-dichlorophenyl) -2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate. The synthesized impurity structure was confirmed by NMR and MS, the impurity content reached 98%.