Impureza (1r | 4r)-4-((2-amino-4-bromobenzyl)amino)cyclohexanol dihidrocloruro es un subproducto bromado estereodefinido que puede aparecer durante etapas de reducción y formación de sales. Presenta centros quirales definidos y un grupo amina protónico que altera solubilidad y perfil de retención en cromatografía líquida de fase reversa. Su detección se optimiza mediante LC-MS/MS y RMN 1H/13C para confirmar estereoquímica y patrones de fragmentación característicos por el átomo de bromo. La presencia de esta impureza puede afectar la pureza y estabilidad del material farmacéutico y requiere control analítico riguroso | límites especificados y evaluación toxicológica en el desarrollo farmacéutico.
Referencias
Dhillon, S. (2019). Dapagliflozin: A Review in Type 2 Diabetes. Drugs, 79(10), 1135–1146. https://doi.org/10.1007/s40265-019-01148-3
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