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Overview
Cefradine EP Impurity E is a critical degradation product of the first-generation cephalosporin antibiotic Cefradine, utilized primarily for pharmaceutical quality control. It serves as a reference standard to validate synthesis purity and stability profiles under ICH guidelines. The compound features molecular formula C16H17N3O5S and carries CAS No. 68904-58-3. Manufactured via precise semi-synthetic pathways involving acylation of 7-aminocephalosporanic acid derivatives.
Application
- Pharmaceutical QC: Used as an analytical reference standard in HPLC methods to detect trace impurities in bulk drug substances.
- R&D Stability Studies: Applied in forced degradation studies to characterize the chemical stability of Cefradine formulations.
- Regulatory Compliance: Essential for filing regulatory documents (DMF/ANDA) to demonstrate impurity profiling consistency.
Precautions
Store strictly below -20°C in a desiccated environment to prevent hydrolysis. Handle with appropriate PPE including gloves and goggles due to potential sensitization risks. Do not use as a therapeutic agent; this material is intended for laboratory research and quality assurance purposes only.