Pantoprazole Related Compound 2 (CAS 72830-09-2) é uma impureza relacionada ao pantoprazol frequentemente identificada como produto de degradação durante estresse ácido | básico ou oxidativo. Sua presença requer investigação toxicológica e definição de limites em especificações por afetar pureza e perfil de segurança do API. Caracterização analítica é realizada por HPLC com detecção UV e confirmação por LC-MS e Ressonância Magnética Nuclear para estabelecer massa molecular | estrutura e vias de formação. Estratégias de controle incluem otimização do processo | condicionamento de estabilidade e desenvolvimento de padrões de referência para quantificação robusta e monitoramento em lote a lote.
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