Losartan EP Impurity B é uma impureza hidroxilada relacionada estruturalmente ao Losartan | também referida como Losartan Hydroxy Impurity | Candesartan Hydroxy Impurity ou Irbesartan Hydroxy Impurity. Seu aparecimento decorre de reações de hidrólise e oxidação durante síntese | armazenamento ou processamento. A identificação e quantificação são realizadas por HPLC acoplada a detectores UV e LC-MS/MS para confirmação de massa e fragmentação. Controle analítico conforme diretrizes ICH Q3A/Q3B exige limites de aceitação | limites de quantificação e métodos validados com recuperação e reprodutibilidade demonstradas. A presença desta impureza pode afetar pureza farmacotécnica e estabilidade do lote | exigindo monitoramento rigoroso e estratégias de redução.
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