Amikacin Sulfate Impurity E (As per 35.1 EP Monograph); 6-O-(6-amino-6-deoxy-a-D-glucopyranosyl)-4-O-[5-[[(2S)-4-amino-2-hydroxybutanoyl]amino]-3-deoxy-a-Dglucopyranosyl]-2-deoxy-D-streptamine
Beschreibung
Amikacin EP Impurity E (Sulfat-Salz) ist eine definierte verwandte Substanz des Aminoglykosids Amikacin und entspricht einem sulfatierten Derivat innerhalb des polyhydroxylierten Aminocyclitol-Glykosid-Gerüsts. Mit der Summenformel C22H45N5O17S und einer Molmasse von 683,68 g/mol ist die Verbindung mit einem geladenen Sulfatgegenion und ausgeprägter Polarität vereinbar, was Retention und Ionisation chromatographisch stark beeinflusst. Solche Verunreinigungen können bei semisynthetischer Modifikation, Salzbildung oder kontrollierter Degradation des Ausgangsantibiotikums entstehen. Die Charakterisierung und Bestimmung erfordern typischerweise Ion-Pair- oder HILIC-LC-MS/MS, hochauflösende MS sowie orthogonale IC- oder NMR-Bestätigung im regulatorischen Impurity-Profiling.
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