This research synthesizes and characterizes a potentially toxic nitrosamine impurity in levofloxacin, highlighting its significance for safety regulation.
Levofloxacin is an antibiotic belonging to the fluoroquinolone family. N-Demethyllevofloxacin, a metabolite and an impurity of levofloxacin, features a secondary amine that is susceptible to N-nitrosation, raising concerns about the formation of a potentially toxic nitrosamine. The corresponding N-nitrosamine was synthesized in two steps and characterized using HRMS, NMR spectroscopy, IR spectroscopy, UV absorption and emission spectroscopies and powder X-ray diffraction. This work provides a reliable reference for the quantitation and control of nitrosamine impurities associated with levofloxacin in chemical and pharmaceutical contexts.
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Maestri et al. (2026) studied this question.
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