A impureza dímero de Eltrombopag representa uma variante de ligação covalente resultante de acoplamento intermolecular durante síntese ou armazenamento | exigindo avaliação rigorosa no perfil de impurezas do princípio ativo. Sua presença pode afetar pureza | estabilidade e quantificação analítica | sendo monitorada por métodos cromatográficos e espectrométricos como HPLC | LC-MS e RMN para identificação estrutural e quantificação. Investigações de mecanismo de formação e estudos de forçamento ajudam a definir condições de mitigação | limites de aceitação e procedimentos de limpeza. O controle desta impureza é crítico para conformidade com diretrizes regulatórias e para garantir segurança e qualidade do produto farmacêutico final.
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