Simplified approach for structural elucidation and quantitation for pharmaceutical API and related impurities

Various guidelines require the impurities of drug substance and drug product be structurally identified and quantitated based on dosage. Source of these impurities could be innumerable based on raw material, process, product, packaging etc.
In this study, a workflow is demonstrated for deducing probable structure of Paracetamol related impurities using Shimadzu LCMS-9030 and Insight Explore software.