Palonosetron EP Impurity C ist die chirale Amidverunreinigung (S)-N-((S)-quinuclidin-3-yl)-1,2,3,4-tetrahydronaphthalin-1-carboxamid, eine nichtflüchtige, basische stickstoffhaltige verwandte Substanz mit der Summenformel C18H24N2O und einer Molmasse von 284,40 g/mol. Die Struktur weist auf den Erhalt des Tetrahydronaphthalin-Amidgerüsts sowie eines Quinuclidin-Stereozentrums hin, was mit einem Syntheseintermediat oder einem während Kopplungs- oder Epimerisierungsschritten entstehenden Stereoisomer vereinbar ist. Da es sich nicht um ein Nitrosamin oder einen klassischen DNA-reaktiven Spurenstoff handelt, liegt der regulatorische Fokus auf dem Verunreinigungsprofil und nicht auf einer ICH-M7-Klassifizierung. Der Nachweis erfolgt typischerweise mittels RP-LC mit UV und Bestätigung durch LC-MS/MS sowie orthogonaler Charakterisierung durch NMR oder hochauflösende Massenspektrometrie.
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