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
Roxithromycin Impurity K is a critical synthetic intermediate and degradation product used in the pharmaceutical manufacturing of Roxithromycin, a macrolide antibiotic. Its synthesis typically involves specific oxidation or hydrolysis steps during the core macrocyclization process. The compound is identified by CAS No. 150786-88-4 and molecular formula C21H37NO9.
Application
- Quality Control: Serves as a reference standard for HPLC method validation to ensure API purity.
- R&D Development: Utilized in stress testing to evaluate stability profiles under various environmental conditions.
- Regulatory Compliance: Essential for generating toxicological data required by FDA and EMA dossiers.
Precautions
- Storage: Maintain in tightly sealed containers at -20°C under inert atmosphere to prevent degradation.
- Safety: Handle with PPE; avoid inhalation and skin contact due to potential sensitization risks.
- Usage: Strictly for research use only; not intended for direct clinical administration.