La impureza D de leflunomida según la EP, CAS 42831-50-5, corresponde al metabolito de bajo peso molecular ácido 5-metilisoxazol-4-carboxílico, con fórmula C5H5NO3 y masa molecular de 127,10 g/mol. Es un ácido carboxílico heteroaromático asociado con la síntesis de leflunomida y su degradación metabólica, reflejando la ruptura del farmacóforo enlazado como anilida. En el contexto regulatorio, su presencia es relevante para el perfil de impurezas y la comprensión del proceso, no para clases estructurales de alerta como las nitrosaminas. Su cuantificación suele requerir LC-MS/MS o UHPLC acoplada a MS de alta resolución, con confirmación por RMN y análisis de fragmentación por espectrometría de masas.
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