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Overview
Crisaborole Related Compound 1 is a critical impurity standard used in the quality control of the PDE4 inhibitor Crisaborole. Synthesized via oxidative coupling or specific degradation pathways, it serves as a reference for HPLC method validation. The molecular formula is C16H17NO5 with CAS No. 1268097-66-2.
Application
- Pharmaceutical Manufacturing: Used as an analytical standard to identify and quantify trace impurities during active pharmaceutical ingredient (API) synthesis.
- Regulatory Compliance: Essential for supporting IND filings and stability studies to meet ICH Q3A/B guidelines.
- R&D Laboratories: Employed in stress testing to evaluate the degradation profile and shelf-life of Crisaborole formulations.
Precautions
- Storage: Maintain at -20°C in a desiccated environment under inert atmosphere to prevent hydrolysis.
- Safety: Handle with appropriate PPE; classified as a potential irritant requiring fume hood usage.
- Limits: Strictly for research use only; not approved for clinical administration or human consumption.