Atorvastatin EP-Impurity F, auch als Atorvastatin-Amid-Säure, Di-Amid-Säure oder Diamino-Verunreinigung in freier Base bezeichnet, ist eine prozess- und degradationsbedingte verwandte Substanz, die mit der Atorvastatin-Synthese und Nebenreaktionen der Amidkupplung verknüpft ist. Sie entspricht CAS 887196-24-9, der Summenformel C40H48FN3O8 und einer Molekülmasse von 717,84 g/mol. Die Struktur weist auf Überaktivierung oder hydrolytische Umlagerung der Amidfunktion der Seitenkette hin, nicht auf eine klassische mutagene Warnstruktur. Die Charakterisierung erfordert typischerweise LC-MS/MS, hochauflösende MS sowie orthogonale HPLC-UV- oder LC-ELSD-Verfahren, bei Isolierung ergänzt durch NMR. Die Bewertung erfolgt im Rahmen des impurity profiling und der Spezifikationsfestlegung nach pharmakopöischen und ICH-Vorgaben.
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