As a result, quality control laboratories utilise a variety of methodologies such ultraviolet (UV) or fluorescence (FLR) detection coupled with liquid chromatography (LC), electrophoresis and imaged capillary isoelectric focusing (icIEF) for the comprehensive evaluation of these products . These analytical methods can be developed specifically for each individual molecule and require validation as per International Council for Harmonization (ICH) and/or Food and Drug Administration (FDA) guidelines to ensure they are fit for use 4 . This results in two main issues when implementing the quality-by-design (QbD) approach recommended by regulatory authorities . The time required to develop and validate these methods is costly. In conjunction with the initial cost and time required for development and validation, routine use in the QC environment can become tedious if the laboratory tests a variety of molecules with a multitude of assays for each. With these issues in mind and the advances in easy to use MS instruments and software compliance of chromatography data systems (CDS), laboratories have been introducing mass spectrometry (MS) based assays into the QC environment for routine use .