A Impureza 10 do fenofibrato (Fenofibrate Impurity 10 | CAS 34183-01-2) é uma impureza relacionada ao processo de síntese e/ou degradação térmica do princípio ativo. Apresenta importância analítica por afetar pureza | perfil de impurezas e cumprimento de limites regulatórios. É caracterizada por cromatografia líquida de alta eficiência com detecção UV e confirmada por LC-MS e RMN para identificação estrutural. Métodos validados de quantificação garantem limite de detecção e recuperações aceitáveis. O controlo inclui otimização de etapas de reação | purificação e condições de armazenamento. Estudos de estabilidade e especificações conforme orientações ICH são recomendados para limitar sua presença no lote final.
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