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Overview
Ebastine Impurity 1, chemically identified as 4-[4-(4-chlorobenzhydryl)piperidin-1-yl]-2-butyn-1-one, is a critical synthetic intermediate and reference standard in the manufacturing of Ebastine. Produced via precise alkylation and coupling reactions, its molecular formula is C22H24ClNO (CAS No. 103687-53-0).
Application
- Pharmaceutical QC: Serves as an analytical reference standard for HPLC/GC method validation to ensure drug purity.
- R&D: Utilized in stability studies to identify degradation pathways during formulation development.
- Regulatory Compliance: Essential for generating impurity profiles required by ICH guidelines for new drug applications.
Precautions
Strictly controlled as a pharmaceutical intermediate; not intended for direct clinical administration. Store under inert atmosphere at -20°C to prevent oxidation. Handle with appropriate PPE to avoid dermal exposure or inhalation.