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Overview
Omeprazole Impurity 41 is a critical reference standard for the quality control of proton pump inhibitors. Synthesized via oxidative pathways, its molecular formula is C17H18N4O3S2 (CAS: 159670-69-8).
Application
- Pharmaceutical QC: Used as an analytical standard in HPLC methods to detect trace levels during drug substance manufacturing.
- R&D: Employed in stability studies to evaluate degradation profiles under stress conditions.
- Regulatory Compliance: Supports ICH Q3A/B guidelines for impurity qualification in global filings.
Precautions
- Storage: Maintain at -20°C in airtight containers protected from light and moisture.
- PPE: Handle in fume hoods wearing nitrile gloves and safety goggles to prevent dermal absorption.