La impureza F de buspirona EP, también denominada impureza dímera de anillo abierto de buspirona, es un degradante dimérico relacionado con el proceso y asociado a la apertura estructural del esqueleto azaspirobuspirona durante la síntesis o tras exposición a estrés. El CAS 2512210-24-9 corresponde a C33H51N9O3 con un peso molecular de 621,82 g/mol. Presenta varios átomos de nitrógeno básicos y un marco no ciclado de tipo diamina, lo que modifica su comportamiento cromatográfico y su fragmentación por espectrometría de masas. Su detección y cuantificación a nivel traza suelen requerir LC-MS/MS, con apoyo de MS de alta resolución y métodos ortogonales de LC en fase reversa o con par de iones. Su control se integra en perfiles de impurezas farmacopéicas e ICH.
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