Prucalopride Impurity D (Prucalopride Related Compound 7, CAS 182808-04-4) é um composto relacionado identificado como impureza de processo e degradação do prucaloprida. A descrição técnica inclui estrutura e massa molar conhecidas por caracterização por LC-MS e RMN, e propriedades fisicoquímicas relevantes para purificação e quantificação. A detecção e quantificação são asseguradas por métodos validados de cromatografia líquida de alta eficiência HPLC com detecção UV e confirmação por espectrometria de massa. Estratégias de controlo incluem otimização de parâmetros de síntese, etapas de purificação e limites de especificação segundo guidelines ICH, além de testes de estabilidade para monitorizar formação e redução desta impureza.
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