Organic impurities may arise during the manufacturing process and/or storage of the drug substance, and can be identified or unidentified, volatile, or nonvolatile. Impurity profiling can act as a quality control tool which can provide crucial data regarding the toxicity, safety, various limits of detection and limits of quantitation of several organic impurities, usually accompany with APIs and finished products.
This application brief describes use of an Epic™ C18 column with the LC 300 liquid chromatography system and SimplicityChrom™ chromatography data system (CDS) for the organic impurity analysis of Levetiracetam, in Accordance with the United States Pharmacopeia (USP).