Shenzhen Excellent Biomedical Technology Co.,Ltd.(SZEB) is a leading supplier of high quality pharmaceutical impurities,API related compounds,intermediates,labeled standards and impurity custom synthesis services.E-mail:sales@ex-biotech.com.
Discover all our products through our official website (https://www.ex-biotech.com/), and get in touch if you have any questions about how we can help support your work. Email:sale@ex-biotech.com.
*The following content is generated by AI and is for reference only.
Overview
Omeprazole Related Compound 9 is a critical degradation impurity of the proton pump inhibitor Omeprazole, primarily generated during acidic hydrolysis or thermal stress. It serves as a vital reference standard for purity profiling in pharmaceutical manufacturing. The compound features the molecular formula C17H18N2O3S and is identified by CAS number 108691-57-4.
Application
- Quality Control: Used to validate HPLC methods for detecting trace impurities in bulk drug substances.
- R&D: Employed in stability-indicating studies to assess formulation robustness under ICH guidelines.
- Regulatory Compliance: Essential for generating toxicological data required by FDA and EMA submission dossiers.
Precautions
- Storage: Maintain at -20°C in airtight containers protected from light and moisture.
- Safety: Handle with appropriate PPE; avoid inhalation or skin contact due to potential mutagenicity.
- Usage: Strictly for research purposes only; not approved for clinical administration.