Formoterol EP Impurity B (sal de fumarato) | CAS 1795137-04-0 | é uma impureza relacionada ao processo e à degradação identificada no perfil de pureza de lotes de Formoterol. Caracterizada por técnicas analíticas como HPLC com detecção UV | LC-MS e confirmação estrutural por RMN e FTIR | apresenta comportamento cromatográfico e propriedades fisicoquímicas que exigem monitoramento durante síntese e purificação. Sua presença influencia a aceitabilidade de especificações e demanda estabelecimento de limites | estudos de qualificação e métodos de controle robustos. A identificação precoce e o uso de padrões de referência permitem mitigação por otimização de rota sintética e etapas de purificação.
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