Lercanidipine Inhouse Impurity D, auch als dehydro Lercanidipine bezeichnet, CAS 887769-34-8, ist ein oxidierter prozess- oder abbauassoziierter Analogon des Dihydropyridin-Calciumkanalblockers Lercanidipin. Die Summenformel C36H39N3O6 und die Molekülmasse 609,71 g/mol entsprechen einer formalen Dehydrierung des Ausgangsgerüsts, verbunden mit einer Änderung des Oxidationszustands und des chromatographischen Verhaltens. Solche Verunreinigungen werden typischerweise mittels stabilitätsindikativer HPLC mit Diodenarray-Detektion getrennt und durch LC-MS/MS bestätigt, wobei HRMS für die Elementzusammensetzung nützlich ist. Die Substanz ist im Rahmen von ICH Q3A und Q3B für das Verunreinigungsprofil relevant.
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