A impureza Prucalopride Dechlorinated Derivative (sal cloridrato) é um derivado resultante da perda do átomo de cloro no anel aromático do prucaloprido | caracterizando-se por massa molecular reduzida e alteração de lipofilicidade. Este degradante afeta o perfil de pureza e pode influenciar a estabilidade e potência do lote. Detectável e quantificável por HPLC com detecção UV e por LC-MS/MS para identificação estrutural | requer métodos validados e limites de especificação em conformidade com diretrizes regulatórias. Estratégias de controle incluem otimização de síntese | condições de purificação e testes de degradação forçada para mitigar geração e assegurar qualidade do produto.
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