广州隽沐生物科技股份有限公司成立于2014年,是一家集医药研发、生物技术服务(原辅料生产)和市场营销为一体的高新技术企业;公司严格按照ISO9001和CNAS管理体系进行产品质量管理,于2019年通过中国食品药品检定研究院现场核查,正式成为标准物质原料供应商。
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Overview
Esomeprazole sodium impurity 1 is a critical reference standard used in the pharmaceutical manufacturing of esomeprazole. It serves as an identified degradation product or synthetic byproduct, characterized by the molecular formula C17H19N3O2S and CAS number 160849-53-6. This compound is essential for validating purification processes and ensuring drug substance purity.
Application
- Quality Control: Used as a calibration standard for HPLC and GC methods to quantify trace levels in active pharmaceutical ingredients.
- R&D: Employed in stability studies to understand degradation pathways under various stress conditions.
- Regulatory Compliance: Required for dossier submissions to agencies like the FDA and EMA to demonstrate control over genotoxic impurities.
Precautions
- Storage: Must be stored in a cool, dry place below -20°C under inert atmosphere to prevent hydrolysis.
- Safety: Handle with appropriate PPE; avoid inhalation or skin contact due to potential irritancy.
- Usage: Strictly for research and analytical use only; not intended for human clinical administration.