Epinastine Impurity 3 (DiHCl) é uma impureza relacionada do processo de síntese de epinastina | tipicamente identificada como o sal dihidrocloridrato. Apresenta comportamento cromatográfico distinto e é monitorada por HPLC e LC-MS para caracterização e quantificação. Sua formação pode decorrer de condições de salificação ou de degradação durante síntese e armazenamento. O controle analítico inclui padrões de referência | limites de aceitação alinhados com ICH Q3A e validação de métodos. Avaliação de pureza | perfil de impurezas totais e estudo de estabilidade são essenciais para mitigar riscos toxicológicos e garantir conformidade.
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