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*The following content is generated by AI and is for reference only.
Overview
Cefradine Impurity 3, chemically (2-Amino-2-cyclohex-1-enyl)propionic acid methyl ester hydrochloride, is a critical reference standard used in pharmaceutical quality control. It serves as an essential degradation product and synthetic intermediate for the cephalosporin antibiotic Cefradine (CAS: 15686-71-2). The molecular formula is typically represented as C10H18ClNO2. This compound is manufactured via precise organic synthesis to ensure high purity for analytical validation.
Application
- Quality Assurance: Used as a certified reference material for HPLC method validation and impurity profiling.
- R&D: Serves as a structural analog for studying metabolic pathways and stability of beta-lactam antibiotics.
- Regulatory Compliance: Required for filing dossiers with agencies like FDA or EMA to define acceptable limits.
Precautions
This substance is intended for research and analytical use only, not for human or veterinary therapeutic administration. Store under inert atmosphere at 2-8°C to prevent hydrolysis. Personnel must wear appropriate PPE including gloves and eye protection when handling to avoid skin contact and inhalation of dust.