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*The following content is generated by AI and is for reference only.
Overview
Oseltamivir Impurity 64 is a critical reference standard for pharmaceutical quality control, specifically serving as an identified degradation product or synthetic intermediate in the manufacturing of oseltamivir phosphate. The compound is characterized by its specific structural configuration relative to the active pharmaceutical ingredient (API). Its molecular formula is C17H28N2O5 and CAS number is 196072-78-7. Production typically involves precise organic synthesis steps ensuring high purity levels suitable for analytical validation.
Application
- Quality Control: Used in HPLC method development and validation to establish impurity profiles.
- Stability Testing: Serves as a benchmark for identifying degradation pathways during shelf-life studies.
- R&D: Assists chemists in optimizing synthetic routes and understanding reaction mechanisms.
Precautions
- Storage: Must be stored under inert atmosphere at -20°C to prevent hydrolysis or oxidation.
- Safety: Handle with appropriate PPE; avoid direct skin contact and inhalation of dust.
- Regulatory: Not for clinical use; strictly limited to laboratory research and analytical calibration.