Metoprolol EP-Impurity D, auch als Metoprolol Related Compound E bezeichnet, ist eine definierte prozessbedingte Verunreinigung des Beta-Adrenozeptorblockers Metoprolol. Die CAS-Nummer 62572-90-1 gehört zu einer neutralen organischen Spezies mit der Summenformel C12H18O4 und einer Molekülmasse von 226,27 g/mol. Strukturell handelt es sich um ein hydroxyliertes und oxidiertes Seitenketten-Derivat und nicht um ein Nitrosamin oder ein anderes bekannt mutagenes Grundgerüst. Ihr Auftreten ist typischerweise mit synthetischen Nebenreaktionen oder oxidativen Umsetzungen während Herstellung und Lagerung verbunden. Identifizierung und Spurengehaltsbestimmung erfordern üblicherweise orthogonale LC-MS/MS-, HPLC-UV- und bei Bedarf NMR-Bestätigung im Rahmen pharmazeutischer und ICH-konformer Verunreinigungskontrolle.
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