Cefdinir Lactone, CAS 946573-41-7, is a defined related substance of cefdinir formed by intramolecular lactonization and rearrangement of the oxime-containing cephalosporin scaffold. With formula C14H13N5O5S2 and molecular weight 395.41 g/mol, it represents a structurally specific degradation product rather than a process impurity. Its presence is most relevant under acidic, thermal, or hydrolytic stress, where β-lactam derived heterocycle transformations may occur. Quantification typically requires LC-MS/MS or high-resolution LC-MS, often complemented by HPLC-UV for separation profiling. The impurity is evaluated within impurity control strategies for cephalosporin drug substances and degradant characterization.
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