Atorvastatin Acyl-β-D-glucuronide (CAS 463962-58-5) é uma impureza metabolítica crítica encontrada em formulações e amostras de atorvastatina; sua presença influencia o perfil de degradação | estabilidade e segurança do produto. A detecção e quantificação exigem métodos analíticos sensíveis como HPLC acoplado a detector UV e LC-MS/MS para caracterização estrutural e confirmação por espectrometria de massas. O monitoramento desta impureza é essencial para conformidade com guidelines regulatórias ICH relativas a impurezas e para definição de especificações | limites de aceitação e controles de processo durante síntese | purificação e estudos de estabilidade.
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