Epinastine EP Impurity B | conhecida também como 7-Bromo Epinastine (HBr) | é uma impureza bromada observada no processo e na degradação de epinastina. Caracteriza-se por substituição por bromo no anel aromático e pode originar-se por reações de bromação acidental ou contaminação do reagente. A sua quantificação e perfil de impurezas são realizados por HPLC com confirmação por LC-MS e caracterização estrutural por RMN. Estratégias de controle incluem otimização de matérias primas | condições de síntese e testes de estabilidade forçados. Deve ser estabelecido um limite aceitável conforme orientação ICH e disponibilizado padrão de referência para controlo de qualidade.
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