N-Didesmetil Bedaquilina (mistura de enantiômeros) | também referida pela descrição (1S | 2R)-4-amino-1-(6-bromo-2-metoxiquinolin-3-yl)-2-(naftalen-1-il)-1-fenilbutan-2-ol | é uma impureza de processo caracterizada pela perda de dois grupos metil do átomo de nitrogênio do composto pai e pela existência de estereoisômeros. Apresenta polaridade aumentada em relação à bedaquilina | comportamento cromatográfico distinto e massa molecular reduzida correspondente à desmetilação | o que exige monitoramento por LC-MS e confirmação por RMN. A presença desta impureza pode afetar pureza e perfis de estabilidade | sendo crítica sua quantificação por HPLC | análise quiral e controles analíticos em desenvolvimento e liberação de lote.
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