4′-O-Demethyl Pantoprazole Sulfide (CAS 141854-21-9) é uma impureza relacionada ao pantoprazole que surge por desmetilação e redução do enxofre durante rotas sintéticas ou sob condições de armazenamento inadequadas. Do ponto de vista de controle de qualidade é crítica a sua detecção e quantificação por cromatografia líquida de alta eficiência com detecção UV em conjunto com LC-MS para confirmação estrutural. A presença desta impureza pode alterar o perfil de pureza e exigir avaliação toxicológica | sendo monitorada segundo limites regulatórios aplicáveis. Estratégias de mitigação envolvem otimização de etapas reacionais | purificação adicional e estudos de estabilidade acelerada para reduzir sua formação.
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