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*The following content is generated by AI and is for reference only.
Overview
Cefotiam double bond transffer impurity is a critical process-related byproduct formed during the synthesis of the cephalosporin antibiotic Cefotiam. This structural variant arises from stereochemical shifts in the dihydrothiazine ring system, necessitating rigorous control. Molecular Formula: C16H18N5O6S2; CAS No.: Not publicly listed as a commercial grade standard due to its nature as an impurity.
Application
- Quality Control: Used as analytical reference standards for HPLC method validation and impurity profiling in pharmaceutical manufacturing.
- R&D: Employed in stability studies to assess degradation pathways and optimize synthetic routes for high-purity API production.
- Regulatory Compliance: Essential for generating toxicological data required by FDA and EMA guidelines for drug substance registration.
Precautions
- Storage: Maintain at -20°C in desiccated conditions under inert atmosphere to prevent hydrolysis or oxidation.
- Safety: Handle with appropriate PPE; potential sensitization risks require containment in fume hoods.
- Usage: Strictly for laboratory analysis only; not intended for clinical administration or human exposure.