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*The following content is generated by AI and is for reference only.
Overview
Sertraline EP Impurity C HCl (1S,4S-Isomer) is a critical reference standard for pharmaceutical quality control. It represents the 1S,4S stereoisomeric impurity of Sertraline hydrochloride, utilized to validate synthesis purity and stability profiles in compliance with European Pharmacopoeia standards. The compound features the molecular formula C17H18ClNO and is identified by CAS number 109275-67-2.
Application
- Quality Control: Used as an analytical reference standard in HPLC methods to detect and quantify trace impurities in bulk drug substances.
- R&D Validation: Employed during process development to monitor chiral separation efficiency and ensure stereochemical integrity.
- Regulatory Compliance: Essential for generating data required in regulatory filings to demonstrate adherence to ICH Q3A/B guidelines.
Precautions
- Storage: Maintain at -20°C in sealed, moisture-proof containers away from direct light.
- Safety: Handle in a fume hood; wear appropriate PPE including gloves and eye protection due to potential irritancy.
- Usage Limitation: Strictly for laboratory research and analytical use only; not intended for clinical administration or therapeutic applications.