A Alogliptin Hydroxy Impurity é uma impureza de processo e degradação resultante da introdução de um grupo hidroxila no núcleo da alogliptina | aumentando polaridade e massa molecular em +16 Da | identificável por LC-MS e confirmável por RMN. Apresenta tempo de retenção menor em cromatografia reversa | maior afinidade por fases polares e susceptibilidade à oxidação e conjugação. Estudos forenses de estabilidade apontam formação via hidrólise oxidativa sob condições alcalinas e iluminação. Controle analítico inclui métodos HPLC validados | limites de especificação compatíveis com Q3A/Q3B | estratégias de purificação e monitoramento em lote para garantir conformidade e segurança farmacêutica.
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