Regorafenib EP Impurity A, también denominado Regorafenib Related Compound A, se identifica con CAS 757251-39-1 y presenta la fórmula molecular C13H12FN3O2 con un peso molecular de 261.26 g/mol. La estructura corresponde a un intermedio sintético definido o a una impureza relacionada con el proceso asociada con la construcción del motivo heteroarílico fluorinado sustituido presente en regorafenib. Estas especies se controlan habitualmente en los perfiles de impurezas, ya que su presencia puede indicar conversión incompleta, reacciones secundarias o arrastre de precursores. Su determinación suele requerir LC-MS de alta resolución, LC-MS/MS y HPLC específica para impurezas con detección UV, con confirmación estructural mediante RMN cuando sea necesario.
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