Bacitracin EP Impurity O, also designated Bacitracin J1, is a higher homologous cyclic dodecapeptide impurity related to the bacitracin A/B/C complex, typically arising from fermentation-derived microheterogeneity and post-biosynthetic processing of Bacillus licheniformis products. With molecular formula C65H101N17O16S and molecular weight 1408.7 g/mol, it retains the characteristic thiazoline-containing peptide architecture of the bacitracin family. Structural assignment and trace-level quantification generally require high-resolution LC-MS, LC-MS/MS, and peptide mapping rather than routine UV methods, due to closely related isobaric analogues and sequence variants. It is not a nitrosamine or ICH M7-class DNA-reactive impurity.
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