Escitalopram Acid, 5-cyano-2-(4-(dimethylamino)-1-(4-fluorophenyl)-1-hydroxybutyl)benzoic acid, is a polar acidic degradation impurity observed during synthesis and stability of escitalopram. It can form via oxidative hydrolysis and exhibits increased polarity relative to the parent amine, leading to early HPLC retention and a characteristic [M-H]- ion in LC-MS. Control strategies include validated HPLC-UV and LC-MS assays, forced degradation profiling, and NMR confirmation for structural assignment. Specification limits are set based on ICH impurity thresholds and toxicological assessment. Monitoring this impurity is essential for API quality, process optimization, and regulatory compliance.
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