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*The following content is generated by AI and is for reference only.
Overview
Crisaborole Impurity 1 is a critical reference standard used in the pharmaceutical industry for quality control of Crisaborole, a topical PDE4 inhibitor. This compound serves as an essential tool for validating synthesis purity and stability profiles during drug development.
Molecular Formula: C
16H
20N
4O
5
CAS Number: 173397-48-5
It is typically synthesized via specific coupling reactions involving substituted pyrazolo-pyrimidine derivatives.
Application
- Quality Control: Used as a certified reference material to identify and quantify trace impurities in active pharmaceutical ingredients (APIs).
- R&D Validation: Employed in method development to calibrate HPLC and LC-MS systems for detecting related substances.
- Regulatory Compliance: Supports regulatory submissions by providing data on impurity profiling required by FDA and EMA guidelines.
Precautions
- Storage: Store in a cool, dry place under inert atmosphere at -20°C to prevent degradation.
- Safety: Handle with appropriate PPE; avoid direct skin contact and inhalation of dust.
- Usage Limit: Intended solely for laboratory research and analytical calibration, not for clinical administration.