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Overview
Cefazolin EP Impurity G is a critical reference standard defined by the European Pharmacopoeia for the quality control of cefazolin sodium. This degradation product typically arises during synthesis or storage, characterized by hydrolysis of the beta-lactam ring. Its molecular formula is C14H15N3O4S2 and CAS number is 68932-74-3.
Application
- Pharmaceutical QC: Used as an analytical standard to identify and quantify impurities in bulk drug substances.
- R&D: Supports stability-indicating method development and validation for cephalosporin formulations.
- Regulatory Compliance: Ensures adherence to ICH Q3A guidelines for specified impurities in finished products.
Precautions
- Storage: Maintain at -20°C in a desiccated environment to prevent hydrolytic degradation.
- Safety: Handle with appropriate PPE; avoid inhalation or skin contact due to potential allergenic properties.
- Usage: Strictly for laboratory research only; not intended for direct clinical administration.