2-[(2-Aminoethoxy) methyl]-4-(2-chlorophenyl)-6-methyl-3,5- pyridine dicarboxylic Acid 3-Ethyl 5-Methyl Ester Fumarate Salt
Descrição
A impureza EP D da amlodipina, também designada Amlodipine Related Compound A, é o sal fumarato de uma impureza piridínica dicarboxilato relacionada à estrutura diidropiridínica, CAS 2138811-33-1. Corresponde a 2-[(2-aminoetoxi)metil]-4-(2-clorofenil)-6-metil-3,5-piridinedicarboxílico ácido 3-etil 5-metil éster, com fórmula molecular C20H23ClN2O5·C4H4O4 e massa molecular de 522,93 g/mol como sal fumarato, 406,0 g/mol como base livre. Esta impureza de प्रक्रिया, estruturalmente definida, pode ser gerada durante a esterificação, ciclização incompleta ou reações secundárias na síntese da amlodipina. A sua determinação requer tipicamente LC-MS/MS, LC-HRMS e HPLC indicativo de estabilidade, com atenção à coeluição em níveis traço e às especificações farmacopeicas.
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