5-Oxo Atorvastatin, CAS 1391052-82-6, ist eine oxidative Verunreinigung des Statin-Gerüsts, gekennzeichnet durch die Ketobildung an der 5-Position der pyrrolbasierten Heptansäure-Seitenkette. Die Summenformel C33H33FN2O5 entspricht einer Molekülmasse von 556,62 g/mol und beschreibt ein monooxygeniertes Atorvastatin-Derivat. Die Bildung ist typischerweise mit oxidativem Abbau während Synthese, Lagerung oder Stressbelastung verbunden und nicht mit einem gezielt hergestellten Zwischenprodukt. Strukturaufklärung und Bestimmung im Spurenbereich erfordern üblicherweise LC-MS/MS, HRMS und stabilitätsindizierende HPLC-Verfahren, ergänzt durch NMR zur eindeutigen Zuordnung. Die Substanz ist für das Verunreinigungsprofil gemäß pharmakopöischen und ICH Q3A/Q3B-Rahmenwerken relevant.
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