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Overview
Cefpodoxime Proxetil EP Impurity D is a critical reference standard used for quality control in the synthesis of cephalosporin antibiotics. It serves as an impurity marker to ensure pharmaceutical compliance with European Pharmacopoeia standards. The compound is characterized by the molecular formula C19H25N5O7S and CAS number 114607-68-2.
Application
- Pharmaceutical QC: Used in HPLC method validation to detect trace impurities during manufacturing.
- R&D Analysis: Serves as a structural analog for degradation studies in stability testing protocols.
- Regulatory Compliance: Essential for generating documentation required by FDA and EMA submissions.
Precautions
- Storage: Maintain at -20°C in a desiccated environment to prevent hydrolysis.
- Safety: Handle with PPE; avoid inhalation or skin contact due to potential allergenic properties.
- Usage: Intended solely for analytical research, not for direct clinical administration.