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*The following content is generated by AI and is for reference only.
Overview
Crisaborole Impurity 10 is a synthetic intermediate utilized in the manufacturing of crisaborole, a non-steroidal PDE4 inhibitor. Its molecular structure serves as a critical reference standard for quality control. The compound is characterized by the molecular formula C10H8N2O2 and CAS number 219675-93-3.
Application
- Pharmaceutical R&D: Employed in method validation and stability testing of final drug products.
- Quality Assurance: Used as an analytical reference standard to identify and quantify trace impurities during production.
- Regulatory Compliance: Supports documentation for FDA and EMA submissions regarding impurity profiling.
Precautions
- Storage: Maintain in a cool, dry place under inert atmosphere at temperatures below -20°C.
- Safety: Handle with appropriate PPE; avoid inhalation or skin contact due to potential sensitization.
- Usage: Strictly for research use only; not intended for direct clinical administration.