Cefepime

Cefepime Impurities

Cefepime is a fourth-generation cephalosporin antibiotic used to treat a wide range of serious bacterial infections. Its impurity profile includes structurally related analogs, residual solvents, and degradation products formed under stress conditions such as hydrolysis, oxidation, and photolysis. Degradation pathways typically involve hydrolytic cleavage of the beta-lactam ring, oxidation of the aminothiazole side chain, and rearrangement of the pyrrolidine moiety. These impurities may affect the drug’s potency, stability, and safety. All impurities are structurally characterized and qualified in accordance with ICH guidelines for toxicological assessment and analytical validation.

Cefepime EP Impurities

Pharmacopeial and non-pharmacopeial Cefepime impurity compounds are available in compliance with European Pharmacopoeia (EP) specifications. These standards support analytical method development, impurity profiling, and long-term stability studies. EP traceable materials are supplied with validated analytical data, including purity, structural confirmation, and spectral characterization.

Cefepime Related Compounds

Structurally related compounds and synthetic analogs associated with Cefepime are included for use in impurity identification, toxicological qualification, and regulatory submission. These related substances are used in forced degradation studies, genotoxicity assessments, and impurity threshold evaluations. They are essential for understanding the impurity profile and ensuring compliance with regulatory limits.

Cefepime Impurity Reference Standards

Cefepime impurity reference standards are provided with validated analytical data, including purity, NMR, MS, and full Certificates of Analysis. These standards are used in pharmaceutical research, method validation, and GMP-compliant quality control. EP/USP traceable entries are available upon request and are routinely re-tested to ensure consistency and reliability.