Hydroxybupropion (CAS 92264-81-8) es una impureza crítica asociada a procesos de síntesis y degradación de bupropión; presenta mayor polaridad que el principio activo y características de retención temprana en métodos cromatográficos de fase reversa. Su identificación y cuantificación se realizan por HPLC con detección UV y confirmación mediante LC-MS para asegurar selectividad y límites de detección adecuados. El compuesto requiere límites de aceptación definidos en especificaciones por su potencial impacto en seguridad y estabilidad del lote. Se recomienda validar procedimientos analíticos | estudiar su perfil de formación bajo estrés químico y térmico y documentar rutas de control en el plan de calidad.
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