Tandem Mass Spectrometry (MS/MS)

Tandem Mass Spectrometry (MS/MS) designates an advanced analytical technique identifying and quantifying molecules by measuring mass-to-charge ratios through sequential mass analysis steps, enabling highly sensitive, specific detection of compounds in complex mixtures. This method supports structural characterisation, impurity profiling, metabolite identification, and biomarker quantification, making it essential for pharmaceutical analysis and bioanalytical testing.

The biopharmaceutical industry employs MS/MS throughout drug discovery, development, and manufacturing quality control. Bioanalytical laboratories use LC-MS/MS methods quantifying drug concentrations in plasma for pharmacokinetic studies, assessing metabolites, and supporting clinical trials. Characterisation of biologics employs MS/MS for peptide mapping, confirmation of amino acid sequences, identification of post-translational modifications, and detection of variants affecting product quality. Impurity analysis detects trace contaminants, degradation products, and residual solvents, supporting regulatory compliance. Method validation ensures accuracy, precision, sensitivity, and reproducibility. Regulatory submissions often include MS/MS data supporting identity, purity, and stability claims. As analytical technology advances enabling higher resolution, faster throughput, and improved quantification, MS/MS continues providing critical capabilities supporting robust product characterisation and reliable decision-making across biopharmaceutical development.