A impureza D da leflunomida na EP, CAS 42831-50-5, corresponde ao metabolito de baixo peso molecular ácido 5-metilisoxazol-4-carboxílico, com fórmula C5H5NO3 e massa molecular de 127,10 g/mol. Trata-se de um ácido carboxílico heteroaromático associado à síntese da leflunomida e à sua degradação metabólica, refletindo a clivagem do farmacóforo ligado por anilida. No enquadramento regulatório, a sua presença é relevante para o perfil de impurezas e para a compreensão do processo, e não para classes de alerta estrutural como nitrosaminas. A quantificação exige normalmente LC-MS/MS ou UHPLC acoplada a MS de alta resolução, com confirmação por RMN e análise de fragmentação por espetrometria de massa.
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