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Overview
Omeprazole EP Impurity D, also known as Omeprazole Sulfone, is a critical reference standard used for the identification and quantification of degradation products in pharmaceutical analysis. Synthesized via the oxidation of omeprazole, it serves as an essential quality control marker under European Pharmacopoeia guidelines. Its molecular formula is C17H18N4O3S2 with CAS No. 117956-06-6.
Application
- Pharmaceutical QC: Used as a primary standard to validate HPLC methods for omeprazole purity testing.
- Stability Studies: Monitors oxidative degradation pathways during drug formulation development.
- Regulatory Compliance: Ensures adherence to ICH Q3B impurity limits for generic drug submissions.
Precautions
- Storage: Maintain in sealed containers at -20°C away from light to prevent oxidation.
- PPE: Operators must wear gloves and goggles; avoid inhalation of dust particles.
- Handling: Use only in certified laboratories equipped with fume hoods.