Impureza 21 de Ezetimibe é um subproduto identificado durante a síntese e armazenamento do princípio ativo | cuja presença exige caracterização rigorosa e controle de processo. Comportamento sob condições de stress indica suscetibilidade a hidrólise e oxidação | tornando essencial o monitoramento por HPLC com detecção UV e confirmação por LC-MS e RMN para elucidação estrutural. A avaliação do perfil de impurezas deve incluir limites aceitáveis em conformidade com as diretrizes ICH Q3A e validação analítica completa | incluindo precisão | linearidade e robustez. Estratégias de controle envolvem otimização de etapas sintéticas e testes de estabilidade para garantir qualidade | segurança e conformidade regulatória.
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