La impureza Bupropion 2-Oxime (CAS 56472-71-0) es un derivado oxima que puede formarse durante la síntesis o la degradación del principio activo y que requiere control riguroso en el perfil de impurezas del API. Su identificación y cuantificación se realiza habitualmente por HPLC con confirmación por LC-MS para garantizar la especificidad analítica. La presencia de esta impureza puede afectar la estabilidad y seguridad del producto terminado | por lo que se establecen límites de especificación | procedimientos de muestreo y condiciones de almacenamiento específicas. Se recomienda disponer de un estándar de referencia certificado y documentación analítica validada para soporte regulatorio y control de calidad.
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