Cefaclor Impurity 21 (CAS 53994-83-5) es una impureza relacionada con la síntesis de cefaclor que requiere control riguroso en el laboratorio de control de calidad; su identificación y cuantificación se realizan habitualmente mediante HPLC con detección UV y LC-MS para confirmar la masa | complementadas por RMN e IR para verificación estructural. Su presencia puede alterar el perfil de pureza y la estabilidad del lote | por lo que se establecen límites conformes a las guías ICH Q3A/Q3B y se documentan procedimientos de aceptación y rechazo. La optimización del proceso y estrategias de purificación son críticas para minimizar su formación y asegurar trazabilidad analítica.
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