Impureza Lisinopril EP Impurity F (CAS 1132650-67-9) | conhecida também como Lisinopril Cyclohexyl analogue | é uma impureza relacionada ao processo que requer monitoramento rigoroso no controle de qualidade de lote. Caracteriza-se por propriedades físico-químicas que podem ser identificadas por HPLC com detecção UV e confirmadas por LC-MS para massa exata | com limites de aceitação estabelecidos conforme diretrizes ICH Q3A/Q3B. A presença desta impureza pode afetar a pureza do API e estabilidade do produto final | exigindo estratégias de redução no processo sintético | especificações analíticas definidas | validação de métodos e testes de desintegração e armazenamento para garantir conformidade regulatória.
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