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*The following content is generated by AI and is for reference only.
Overview
Cephalexin Impurity E, also known as Cefradine EP Impurity G, is a critical degradation product and synthesis intermediate in beta-lactam antibiotic manufacturing. Its molecular formula is C16H17N3O5S with CAS number 24480-19-3. This compound arises primarily during the acylation step or via hydrolysis of the cephalosporin nucleus.
Application
- Quality Control: Used as a reference standard for HPLC method validation to detect trace impurities in bulk API.
- R&D Studies: Essential for stability-indicating methods development and stress testing protocols.
- Regulatory Compliance: Required for dossier submissions under ICH Q3B guidelines to ensure drug safety.
Precautions
- Storage: Maintain in sealed containers at 2-8°C away from light and moisture.
- Safety: Handle with PPE to avoid skin contact; potential allergen for penicillin-sensitive individuals.
- Usage: Strictly for analytical research only; not intended for clinical therapeutic use.