Milrinone O-Glucuronide é uma impureza relacionada formada por conjugação O-glucuronídea da milrinona, frequentemente detectada em estudos de estabilidade e em amostras biológicas após exposição a condições oxidativas e variáveis de pH. A presença desta impureza pode afetar perfis de pureza e exigir investigação toxicológica dependendo do nível detectado. A caracterização exige métodos analíticos sensíveis, tipicamente LC-MS/MS para confirmação estrutural e HPLC com detectores UV para quantificação, além de validação conforme ICH Q2. Estratégias de controle incluem otimização de condições de síntese, controles de processo e armazenamento sob condições controladas para minimizar sua formação e garantir conformidade regulamentar.
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