Betaxolol EP Impurity B (Base Livre) | CAS 62572-94-5 | também referida como Metoprolol EP Impurity H | O-Desmethyl Metoprolol e Betaxolol Hydroxyethyl Analog | é uma impureza estrutural caracterizada pelo grupo hidroxi-etílico ligado ao anel fenólico e pela função propanolamina terciária. Esta impureza apresenta propriedades físico-químicas que influenciam o perfil de pureza do ativo e pode ser detectada e quantificada por HPLC com detecção UV | confirmada por espectrometria de massas e RMN. O monitoramento sistemático é essencial em controle de qualidade para atender especificações farmacopéias e mitigar riscos relacionados à estabilidade do lote.
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