Impureza 21 de Lisinopril é um subproduto identificado durante síntese e degradação que pode afetar o perfil de pureza do lote final. Caracteriza-se por propriedades físico-químicas específicas detectáveis por HPLC com detecção UV e confirmáveis por LC-MS e RMN. A presença da impureza exige estabelecimento de limites de especificação | estudo de impureza de processo e validação de métodos analíticos para quantificação precisa em níveis traço. Avaliações de estabilidade forçam medidas de controle de processo e de formulação para minimizar formação por vias de reação conhecidas. A documentação de risco toxicológico e conformidade com requisitos regulatórios suporta estratégias de mitigação e liberação do produto.
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