Epinefrina Impureza 34 (isômero S) é uma impureza quiral associada a lotes de epinefrina que pode comprometer o perfil de pureza e a atividade farmacológica do princípio ativo. Caracteriza-se por diferenciação enantiomérica e por propriedades fisicoquímicas que tornam sua separação e quantificação desafiadoras em matrizes complexas. Para o controle de qualidade e para estudos de estabilidade a detecção requer métodos analíticos sensíveis e específicos | como cromatografia quiral acoplada a espectrometria de massa | com limites de quantificação adequados e validação robusta. A identificação e quantificação desta impureza são fundamentais para avaliação de risco | conformidade com especificações e aceitabilidade de lote.
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