La impureza (R)-2 | 3-Dihydroxy-5-(1-Hydroxy-2-(Methylamino)ethyl)benzenesulfonic acid es un derivado polar con grupos fenol | alcohol y amina metilada unido a un ácido sulfónico; su quiralidad R y elevada solubilidad acuosa complican su separación del producto principal. Su presencia se monitoriza por HPLC con detección UV | LC-MS para confirmación de masa y RMN 1H para verificación estereoquímica. Se aconseja definir límites de aceptación | realizar perfiles de degradación y estudiar mecanismos de formación durante síntesis y purificación para diseñar controles de proceso efectivos y estrategias de limpieza que minimicen su impacto en la calidad del lote.
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