2-Hydroxy Atenolol (CAS 68373-10-4) is a process-related impurity and oxidative metabolite of atenolol that demands rigorous monitoring in drug substance and product control. This impurity can affect assay accuracy, stability and impurity profiling, therefore detection and quantification at trace levels are essential. Characterization is routinely achieved by HPLC with UV detection and orthogonal confirmation by LC-MS and 1H/13C NMR, supported by infrared spectroscopy and high resolution mass spectrometry when required. Specification setting should follow ICH impurity guidelines with validated analytical methods for limit testing, identification and degradation studies to ensure consistent control of the critical quality attributes.
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