Impureza Aripiprazole Impurity F CRS (CAS 573691-09-5) es un compuesto relacionado detectado en el proceso de síntesis y degradación del aripiprazol; su identificación se realiza por HPLC y LC-MS con confirmación por RMN y FT-IR para caracterizar su espectro y masa exacta. Presenta un perfil cromatográfico reproducible que facilita la cuantificación y establecimiento de límites en especificaciones de control de calidad. Su origen suele atribuirse a rutas secundarias de reacción o degradación química durante síntesis y almacenamiento. La caracterización precisa y datos de pureza son críticos para cumplir guías regulatorias ICH sobre impurezas y asegurar trazabilidad analítica.
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