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*The following content is generated by AI and is for reference only.
Overview
Ceftaroline Fosamil Impurity 31 is a synthetic byproduct of the cephalosporin antibiotic manufacturing process, primarily utilized for quality control and method development. Its molecular formula is C25H27N9O8S2, with CAS No. 1034666-63-5.
Application
- Pharmaceutical QC: Serves as a reference standard to validate HPLC purity assays for Ceftaroline Fosamil drug substances.
- R&D Support: Used in stability-indicating methods to identify degradation pathways during formulation studies.
- Toxicology: Employed in safety assessments to evaluate potential genotoxicity or adverse effects of trace impurities.
Precautions
- Storage: Maintain at -20°C in a dry, inert atmosphere to prevent hydrolysis.
- Handling: Requires PPE (gloves, goggles) due to potential skin irritation; avoid inhalation of dust.
- Regulatory: Strictly limited to laboratory use; not approved for direct clinical administration.