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Overview
Ceftaroline Fosamil Impurity 3 is a critical synthetic intermediate in the pharmaceutical manufacturing of the cephalosporin antibiotic Ceftaroline. It serves as a key reference standard for quality control and process validation. The compound is defined by its molecular formula C18H20N4O5S and identified by CAS No. 906976-56-7. Production involves precise acylation steps ensuring high purity levels suitable for regulatory compliance.
Application
- Quality Control: Used as an analytical reference standard to identify and quantify impurities in active pharmaceutical ingredients (APIs).
- R&D: Employed in stability studies and method development during drug substance synthesis optimization.
- Regulatory Compliance: Essential for submitting impurity profiles to health authorities like the FDA and EMA.
Precautions
- Storage: Maintain in sealed containers at -20°C under inert atmosphere to prevent degradation.
- Safety: Handle with appropriate PPE; avoid inhalation or skin contact due to potential sensitization.
- Usage: Strictly for laboratory research and analytical purposes, not for clinical administration.