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Overview
Ceftaroline Fosamil Impurity 1 is a critical synthetic intermediate in the manufacturing of the cephalosporin antibiotic Ceftaroline. It serves as a reference standard for quality control and process optimization within pharmaceutical synthesis.
- Molecular Formula: C24H26N8O7S2
- CAS Number: 105934-58-9
Application
- Quality Control: Used as an analytical reference standard to validate purity levels during drug substance production.
- Process Development: Monitors reaction pathways to optimize yield and minimize byproduct formation in API synthesis.
- Regulatory Compliance: Supports documentation for ICH guidelines regarding impurity profiling in new drug applications.
Precautions
- Storage: Maintain in a cool, dry place under inert atmosphere to prevent hydrolysis.
- Handling: Requires PPE due to potential sensitization; avoid inhalation of dust.
- Usage: Strictly for R&D and manufacturing analysis; not for direct clinical administration.