Leflunomid-EP-Impurity D, CAS 42831-50-5, entspricht dem niedermolekularen Metaboliten 5-Methylisoxazol-4-carbonsäure mit der Formel C5H5NO3 und einer Molekülmasse von 127,10 g/mol. Es handelt sich um eine heteroaromatische Carbonsäure, die im Zusammenhang mit der Synthese und dem metabolischen Abbau von Leflunomid steht und die Spaltung des anilidisch gebundenen Pharmakophors widerspiegelt. Regulatorisch ist ihr Auftreten für das Impurity-Profiling und das Prozessverständnis relevant, nicht für spezifische Warnklassen wie Nitrosamine. Die Bestimmung erfolgt typischerweise mittels LC-MS/MS oder UHPLC-HRMS, ergänzt durch NMR und MS-Fragmentierungsanalyse zur Unterscheidung von isomeren Verbindungen.
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