Ezetimibe Impurity 55 (CAS 1368310-60-4) é uma impureza relacionada detectada no perfil de impurezas de lotes de ezetimiba | relevante para controle de qualidade e investigação de estabilidade | cuja identificação e quantificação exigem técnicas sensíveis como HPLC com detecção UV | LC-MS para atribuição de massa e NMR para confirmação estrutural; sua presença pode indicar vias de degradação ou impurezas de síntese | influenciando especificações e critérios de aceitação; recomenda-se desenvolvimento e validação de métodos analíticos robustos | uso de padrão de referência certificado e avaliação de limites de aceitação para garantir a conformidade com requisitos regulatórios e segurança do produto.
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