Impureza Bupropion Dihidro (isómeros R | RS) maleato es una variante stereoisomérica observada durante la síntesis y degradación del principio activo que requiere identificación y cuantificación precisas para cumplimiento regulatorio y control de calidad. Su presencia puede afectar la pureza farmacéutica y el perfil de estabilidad | por lo que se recomienda análisis mediante HPLC quiral | LC-MS de alta resolución y corroboración estructural por RMN para determinar configuración y posibles interconversiones. Los límites de aceptación deben basarse en estudios de impurezas relacionadas y niveles tóxicológicos | con métodos analíticos validados que aseguren sensibilidad | especificidad | linealidad y recuperación apropiadas.
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