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*The following content is generated by AI and is for reference only.
Overview
Omeprazole Impurity 23 is a critical degradation product and synthetic intermediate in the manufacturing of Omeprazole. Its molecular structure typically involves specific oxidation states or ring modifications. The standard CAS No. associated with this impurity is often cited as 145769-80-6, though verification against specific batches is required. The molecular formula generally aligns with C17H18N4O3S derivatives depending on the specific isomeric form.
Application
- Quality Control: Used as a reference standard for HPLC method validation to detect trace levels in bulk drug substances.
- Regulatory Compliance: Essential for generating stability-indicating data under ICH Q3A guidelines during pharmaceutical registration.
- R&D: Employed in stress testing studies to understand degradation pathways and optimize synthesis routes.
Precautions
Store in a cool, dry place away from direct sunlight and moisture to prevent hydrolysis. Handle with appropriate PPE including gloves and goggles to avoid skin contact. Strictly limit exposure during clinical trials as it lacks therapeutic efficacy and may possess unknown toxicological profiles at high concentrations.