Atorvastatin EP-Impurity G, auch bezeichnet als 3-O-Methylatorvastatin (freie Base), CAS 887324-53-0, ist eine strukturverwandte, prozess- und abbauassoziierte Verunreinigung des Statin-Gerüsts und keine eigenständige reaktive Klasse wie ein Nitrosamin. Mit der Summenformel C34H37FN2O5 und einer Molmasse von 572,67 g/mol unterscheidet sie sich von Atorvastatin durch O-Methylierung an der 3-Hydroxygruppe, wodurch Polarität und chromatographisches Verhalten verändert werden. Die Entstehung kann auf unvollständige Entschützung, Methyltransfer-Nebenreaktionen oder metabolisch ähnliche O-Alkylierung zurückgehen. Die Spurenbestimmung erfordert üblicherweise LC-MS/MS, hochauflösende LC-MS sowie orthogonale HPLC-UV-Verfahren; die Bewertung erfolgt im Rahmen pharmakopöischer Spezifikationen und der ICH-Impuritätskontrolle.
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