Pravastatin EP Impurity E (CAS 722504-45-2) | também referida como 3″-(S)-Hydroxy Pravastatin (Sodium Salt) | é uma impureza observada no perfil de pureza do pravastatina sódica conforme especificações EP. Caracteriza-se por modificação hidroxilada do núcleo do fármaco e exige identificação e quantificação rigorosas por HPLC com detecção UV | LC-MS e confirmação estrutural por RMN. A avaliação inclui investigação de vias de formação durante síntese e degradação | estabelecimento de limites de especificação | estudo de estabilidade e impacto potencial sobre segurança e eficácia do lote. Dados analíticos e certificados de conformidade suportam o controle de qualidade.
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