Escitalopram EP Impurity K, also identified as Citalopram R-Isomer (CAS 128196-02-1), is a chiral enantiomeric impurity critical to escitalopram quality control. This impurity must be monitored within the impurity profile to ensure enantiomeric purity and compliance with ICH Q3A and Q3B guidelines. Analytical characterization typically employs chiral HPLC, LC-MS and NMR to quantify and confirm stereochemistry and related substance limits. Accurate referencing of Impurity K supports method validation, stability studies and batch release testing. Technical specification data, retention time, and acceptance criteria enable robust control strategies to minimize R-isomer content during synthesis and purification.
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