Prucalopride Succinate Impurity – 2 corresponde ao ácido 4-amino-5-cloro-2,3-diidrobenzofurano-7-carboxílico, CAS 123654-26-2, com fórmula molecular C9H8ClNO3 e massa molecular de 213,62 g/mol. Este ácido carboxílico aminobenzofurânico heteroaromático é compatível com um intermediário relacionado ao processo ou subproduto sintético decorrente de conversão incompleta de grupos funcionais durante a montagem do núcleo de prucaloprida. O motivo de amina aromática clorada requer vigilância, pois impurezas aromáticas em níveis traço podem demandar avaliação toxicológica segundo os princípios do ICH M7 quando presentes em correntes de substância ativa. A caracterização normalmente emprega LC-MS/MS, LC-MS de alta resolução e HPLC-UV ortogonal, com RMN ocasional para confirmação estrutural.
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