Metoprolol EP Impurity E, CAS 163685-38-9, is a defined process-related impurity associated with the beta-adrenergic blocker metoprolol. With molecular formula C15H25NO3 and molecular weight 267.36 g/mol, it is a nonaromatic amino alcohol structure consistent with a synthetic intermediate or side-product arising during etherification, reductive amination, or incomplete chiral resolution. Its chromatographic behavior often requires reversed-phase HPLC coupled with LC-MS/MS for trace-level identification and quantification, with NMR used for structural confirmation when needed. In regulatory impurity profiling, it is evaluated as a specified related substance within pharmacopeial control strategies.
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