5-Chloro Bupropion (CAS 1346603-00-6) es una impureza crítica que puede generarse durante la síntesis de bupropión; la sustitución clorada en la posición aromática modifica polaridad | solubilidad y comportamiento cromatográfico | complicando la separación del API. Su identificación y cuantificación se realizan por HPLC-UV y LC-MS con confirmación mediante RMN 1H/13C | y requiere una resolución analítica robusta frente al compuesto principal. Desde el punto de vista regulatorio se controla según ICH Q3A con límites justificados | ya que su presencia puede afectar pureza y estabilidad. Las estrategias de control incluyen optimización del proceso | recristalización | cromatografía preparativa y monitorización en proceso.
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