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*The following content is generated by AI and is for reference only.
Overview
Cephalexin 7-Epimer is a critical degradation impurity of the antibiotic Cephalexin, formed via epimerization at the C-7 position. It serves as a reference standard for quality control in pharmaceutical manufacturing. Molecular Formula: C16H17N3O5S; CAS No.: 14982-20-6.
Application
- Quality Control: Used to validate HPLC methods for detecting epimeric impurities in bulk drug substances.
- R&D: Essential for stability studies to assess the shelf-life and storage conditions of cephalosporin formulations.
- Regulatory Compliance: Required for filing impurity profiles with FDA and EMA to ensure patient safety standards.
Precautions
- Storage: Maintain in tightly sealed containers under inert atmosphere at -20°C to prevent further degradation.
- Safety: Handle in fume hoods; avoid skin contact as it may cause sensitization or allergic reactions.
- Usage: Strictly for laboratory research and analytical calibration; not intended for clinical therapeutic use.