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Overview
Amlodipine Besylate EP Impurity D Fumarate is a specified degradation product of the calcium channel blocker Amlodipine. It serves as a critical reference standard for chromatographic purity testing in pharmaceutical manufacturing. The compound features the molecular formula C20H25ClN2O4S·C4H4O4 and is identified by CAS No. 164789-45-7.
Application
- Quality Control: Used to validate HPLC methods for detecting trace impurities in bulk drug substances.
- Regulatory Compliance: Essential for dossier submissions to FDA and EMA under ICH Q3B guidelines.
- R&D: Supports stability-indicating studies during formulation development.
Precautions
This substance is not for clinical use. Store in a cool, dry place away from light below 25°C. Personnel must wear appropriate PPE, including gloves and safety goggles, to prevent skin contact and inhalation of dust particles.