Levetiracetam EP Impurity A, also designated levetiracetam carboxylic acid racemate, is the racemic open-chain carboxylic acid related to the pyrrolidone parent drug. CAS 67118-31-4, molecular formula C8H13NO3, molecular weight 171.19 g/mol. It represents a hydrolytic or synthetic degradant arising from ring-opening of the 2-oxopyrrolidine scaffold rather than a reactive genotoxic class. Because it is polar and structurally close to the active substance, its measurement commonly relies on reversed-phase HPLC with UV or LC-MS/MS confirmation, and orthogonal LC-HRMS methods may be required for trace-level impurity profiling in pharmacopoeial and stability studies.
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