NMR And Mass Spectrometry In Pharmaceutical Development

By Joshua Hicks, Ph.D., Senior Scientist, Organic Spectroscopy, Catalent

Nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry (MS) are powerful techniques for the characterization and quantification of compounds. Their applications include the ability to confirm the structure of compounds, determine purity, and identify (and possibly quantify) process-related impurities, degradants, or other unknowns observed during liquid chromatography screening. Together, NMR and MS analysis can definitively identify reference standards, active pharmaceutical ingredients (APIs), or final drug product composition. These techniques can be especially useful for identifying unknown constituents within a sample and/or confirming the identity of materials where there are no reference standards available. In this article, the ability of NMR and MS to characterize product composition is demonstrated using detailed examples.