Fenofibric Acyl Glucuronide é uma impureza de interesse controlada em desenvolvimentos farmacêuticos envolvendo fenofibrato | resultante de conjugação acil-glucurônica que pode formar-se durante síntese | purificação ou estudos de estabilidade. A identificação e quantificação exigem métodos analíticos sensíveis como LC-MS/MS | UPLC-HRMS e HPLC acoplada a detecção adequada | com confirmação estrutural por RMN. Estuda-se sua estabilidade frente a variações de pH | temperatura e matriz e em testes de degradação forçada para definir perfil e vias de formação. Estratégias de controle incluem otimização de processo | controles em processo e validação analítica conforme diretrizes ICH para qualificação de impurezas.
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