Applications of Mass Spectrometry in Pharmaceutical Analysis: Detection of Impurities

Abstract

Mass spectrometry (MS) has become an indispensable tool in pharmaceutical analysis, particularly in detecting impurities that could affect drug safety, efficacy, and regulatory compliance. This review provides an overview of mass spectrometry’s principles, components, and primary techniques, including ionization methods, mass analysers, and detectors. MS plays a vital role in impurity profiling, stability testing, and regulatory compliance by offering high sensitivity, specificity, and quantification capabilities. Case studies highlight successful applications in impurity detection across biopharmaceuticals and small-molecule drugs. Advances in MS technology, such as ultra-high-resolution instruments and integration with liquid chromatography (LC-MS), are further enhancing its effectiveness. Future research is expected to improve sensitivity, specificity, and sample preparation techniques, expanding MS applications in pharmaceutical development.