Sacubitril-(2S,4S)-Isomer, auch als Sacubitril-2-Epimer bezeichnet, CAS 149709-63-7, ist eine stereoisomere, prozessbedingte Verunreinigung des Neprilysin-Inhibitors Sacubitril und kein eigenständiges strukturelles Abbauprodukt. Die Summenformel C24H29NO5 und die Molmasse von 411,49 g/mol kennzeichnen die epimerisierte stereochemische Variante, die bei unvollständiger stereochemischer Kontrolle in der Synthese oder Aufarbeitung entstehen kann. Aufgrund der engen strukturellen Nähe zum Wirkstoff erfordert die Spurendetektion typischerweise chirale HPLC mit orthogonaler Bestätigung durch LC-MS/MS und gegebenenfalls NMR. Die regulatorische Bewertung betrifft Spezifikationen, stereochemische Reinheit und die Kontrolle der Epimerbildung nach den Grundsätzen von ICH Q3A und Q3B.
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