Rosuvastatin impurity 245 (CAS 147118-41-0) é uma impureza identificada no processo de síntese e no perfil de estabilidade da rosuvastatina; sua caracterização estrutural e massa exata são essenciais para a qualificação. Estudos analíticos por HPLC com detector UV e LC-MS/MS permitem quantificação sensível e estabelecimento de limites em conformidade com as diretrizes ICH Q3A e Q3B. A avaliação de origem como degradante térmico ou subproduto de reação possibilita otimização de etapas de processo e estratégias de controle, incluindo purificação cromatográfica e ajustes de pH. Fornece dados críticos para especificações, avaliação de risco toxicológico e compatibilidade do produto final.
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