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Overview
Sertraline EP Impurity B HCl is a critical reference standard for pharmaceutical quality control, specifically designed to monitor the synthesis and degradation of sertraline hydrochloride. Manufactured via precise chemical coupling and salt formation processes, this compound serves as an essential tool for ensuring drug purity in compliance with European Pharmacopoeia (EP) standards. Its molecular formula is C20H21Cl2NO and CAS number is 94867-53-1.
Application
- Quality Control: Used in HPLC method development and validation to identify and quantify trace impurities in active pharmaceutical ingredients.
- R&D: Employed during stability studies to assess degradation pathways and ensure long-term product integrity.
- Regulatory Compliance: Provides necessary data for regulatory filings to demonstrate adherence to strict impurity limits.
Precautions
Store under inert atmosphere at temperatures below -20°C to prevent decomposition. Handle only by trained personnel using appropriate PPE due to potential irritant properties. This material is strictly for laboratory research and analytical calibration; it is not intended for clinical administration or therapeutic use.