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*The following content is generated by AI and is for reference only.
Overview
Cefixime EP Impurity C, also known as Cefixime 7-epimer, is a stereoisomeric impurity formed during the synthesis or degradation of the third-generation cephalosporin antibiotic. It arises from epimerization at the C-7 position of the cephem nucleus. The molecular formula is C16H15N5O6S2 with CAS number 90548-82-6.
Application
- Quality Control: Used as reference standard to identify and quantify related substances in pharmaceutical batches.
- R&D: Employed in stability-indicating method development to assess drug degradation pathways.
- Regulatory Compliance: Essential for meeting ICH Q3A guidelines on impurity thresholds in final API formulations.
Precautions
- Storage: Keep in tightly sealed containers under inert atmosphere at 2-8°C away from light.
- Safety: Handle with appropriate PPE; avoid inhalation or skin contact due to potential sensitization.
- Usage: Strictly for analytical research only; not intended for human therapeutic administration.