Bacitracin EP Impurity B, auch als Bacitracin D2 oder Bacitracin C3 bezeichnet, ist eine eng verwandte Bacitracin-Peptidvariante mit der CAS-Nummer 149146-35-0. Mit der Summenformel C64H99N17O16S und einer Molekülmasse von 1394,66 g/mol gehört sie zum Impuritätsprofil des cyclischen Dodecapeptid-Antibiotikums und kann aus biosynthetischer Mikroheterogenität, enzymatischen Prozessvarianten oder geringfügigem Abbau während Fermentation und Isolierung entstehen. Die starke strukturelle Ähnlichkeit zu Bacitracin A erschwert die chromatographische Trennung und erfordert häufig hochauflösende RP-LC in Kopplung mit UV-Detektion, LC-MS/MS sowie, zur Strukturverifikation, hochauflösende Massenspektrometrie und MS/MS-Fragmentanalyse. Die regulatorische Einordnung ist für das Impurity-Mapping und die Zusammensetzungsprüfung relevant.
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