Trazodona dímero é uma impureza relacionada observada em lotes de síntese e durante estudos de estabilidade da trazodona. Caracteriza-se por massa molecular correspondente ao dímero e por sinais específicos em LC-MS e NMR que diferenciam do monômero. A presença pode indicar acoplamento indesejado durante etapas de acoplagem ou degradação oxidativa. Monitoramento por HPLC com detecção fotométrica e confirmação por LC-MS/MS permite quantificação e identificação estrutural. Avaliação do perfil de impurezas | estabelecimento de limites de especificação e otimização de condições de processo e formulação são essenciais para controle e garantia da qualidade do produto final.
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