Cefazolin EP Impurity I, also designated cefazoloic acid, is a cephalosporin-derived process and degradation impurity associated with hydrolytic opening and rearrangement of the beta-lactam system. With CAS 1675244-99-1, molecular formula C14H16N8O5S3, and molecular weight 472.52 g/mol, it retains the thiazole and sulfonamide-rich scaffold characteristic of cefazolin-related species. Its structural complexity and polarity typically require reversed-phase LC coupled to diode-array detection and LC-MS/MS for definitive identification and quantification, with HRMS useful for fragment assignment. Regulatory evaluation considers it as a specified impurity in pharmacopeial control strategies rather than a classically genotoxic species.
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