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*The following content is generated by AI and is for reference only.
Overview
Atomoxetine EP Impurity C HCl is a specified degradation product and reference standard for the ADHD drug Atomoxetine. Synthesized via chlorination of the parent amine, it serves as a critical quality control marker in pharmaceutical manufacturing.
Molecular Formula: C17H20ClNO·HCl
CAS Number: 184985-65-7
Application
- Quality Control: Used in HPLC method validation to detect trace impurities in bulk API batches.
- Regulatory Compliance: Essential for generating stability data required by ICH guidelines and EMA filings.
- R&D: Employed in stress testing to identify degradation pathways under varying environmental conditions.
Precautions
- Storage: Maintain at -20°C in sealed, light-resistant containers to prevent hydrolysis.
- Safety: Handle with appropriate PPE; avoid inhalation of dust or skin contact due to potential sensitization.
- Limits: Strictly limited to laboratory use; not approved for direct clinical administration.