Cefdinir-3-Methyl-Impurität, CAS 71091-93-5, ist eine definierte prozessbedingte Begleitsubstanz des Cephalosporin-Antibiotikums Cefdinir der dritten Generation mit der Summenformel C13H13N5O5S2 und einer Molmasse von 383,40 g/mol. Strukturell handelt es sich um ein methyliertes Analogon, das typischerweise durch eine Nebenreaktion der Synthese oder unzureichend kontrollierte Alkylierungsschritte entsteht und nicht primär als Abbauprodukt zu betrachten ist. Als β-Lactam-assoziierte Verunreinigung erfordert sie eine stabilitätsindizierende Charakterisierung mittels LC-MS/MS, hochauflösender LC-MS und orthogonaler HPLC-UV-Verfahren im Rahmen von ICH Q3A und pharmakopöischen Grenzwertkonzepten.
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