Bacitracin EP Impurity B, also designated Bacitracin D2 or Bacitracin C3, is a closely related bacitracin peptide variant recorded under CAS 149146-35-0. With molecular formula C64H99N17O16S and molecular weight 1394.66 g/mol, it belongs to the cyclic dodecapeptide antibiotic impurity profile arising from biosynthetic microheterogeneity, enzymatic processing variants, or minor degradation during fermentation and isolation. Its structural similarity to bacitracin A complicates chromatographic resolution, often requiring high-resolution reversed-phase LC coupled to UV, LC-MS/MS, and, where structural confirmation is needed, high-resolution mass spectrometry and tandem fragmentation analysis. Regulatory characterization is relevant for impurity mapping and compositional control in peptide-derived drug substances.
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