Buspirone EP Impurity J, también denominada Buspirone Open Ring Spirodimer Impurity, CAS 2726492-72-2, es una impureza dimérica relacionada con el proceso y asociada al andamiaje espiracíclico azapirónico de la buspirona. Su fórmula molecular, C34H52N6O5, y su peso molecular, 624.81 g/mol, describen una especie de alta masa y no volátil derivada de vías de acoplamiento sintético, apertura de anillo o reordenamientos degradativos durante la fabricación o el almacenamiento. La elucidación estructural suele requerir LC-MS/MS de alta resolución con confirmación por RMN, ya que la detección por HPLC-UV convencional puede no ser suficiente para niveles traza. Aunque no es una nitrosamina, su control es pertinente bajo el marco farmacopeico y los principios ICH Q3A.
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