p-(2-Methoxyethyl)phenol; Metoprolol Impurity I; Metoprolol Impurity B; p-(2-Methoxyethyl)phenol; Metoprolol EP Impurity B
Beschreibung
Metoprolol EP Impurity B, CAS 56718-71-9, ist eine definierte, prozessbezogene Verunreinigung aus dem synthetischen Herstellungsweg von Metoprolol und dem Bereich struktureller Abbauprodukte. Mit der Summenformel C9H12O2 und einer Molmasse von 152,19 g/mol handelt es sich um ein niedrigmolekulares aromatisches Ether-Derivat, dessen Charakterisierung massenselektiv und nicht allein über UV-Detektion erfolgen sollte. Die Bestimmung erfordert typischerweise orthogonale LC-MS/MS-, GC-MS- und hochauflösende LC-MS-Methoden, meist kombiniert mit umgekehrter Phasenchromatographie zur Verunreinigungsprofilierung. Regulativ wird eine solche Spezies im Rahmen pharmakopöischer Grenzwerte und ICH-Konzepten zur Verunreinigungskontrolle bewertet, da sie auf unvollständige Alkylierung, Nebenreaktionen oder Spaltungen der aryloxylierten Seitenkette hinweisen kann.
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