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*The following content is generated by AI and is for reference only.
Overview
Cefditoren impurity 2, also known as Cefditoren open ring, is a critical degradation product formed during the synthesis or storage of the cephalosporin antibiotic Cefditoren. It arises from the hydrolysis of the beta-lactam ring, compromising structural integrity. The molecular formula is C16H18N4O7S, with CAS No. 195065-05-7.
Application
- Quality Control: Serves as a reference standard for HPLC method validation in pharmaceutical manufacturing.
- Potency Testing: Used to assess drug stability and degradation pathways under stress conditions.
- Regulatory Compliance: Essential for defining impurity limits in ICH Q3B guidelines for generic drug approval.
Precautions
- Storage: Maintain at -20°C in a dry, dark environment to prevent further degradation.
- Safety: Handle with appropriate PPE; avoid inhalation of dust or direct skin contact.
- Usage: Strictly for analytical research only; not intended for clinical administration or therapeutic use.