Pravastatin EP Impurity C (CAS 159225-12-4) | também conhecida como Homopravastatin Sodium Salt | é uma impureza relevante no perfil de qualidade de pravastatina. Sua identificação e quantificação são essenciais em controle analítico usando técnicas como HPLC acoplada a detectores UV ou MS para garantir conformidade com especificações farmacopéicas. A impureza pode surgir por vias de síntese incompleta ou degradação durante processamento e armazenamento | impactando pureza e estabilidade do lote. Avaliações de limite de aceitação | estudos de forçamento e métodos de remoção por purificação cromatográfica são práticas recomendadas para mitigar riscos e documentar o perfil de impurezas em dossiês regulatórios.
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