NMR in Pharmaceutical Manufacturing

NMR spectroscopy is a well-recognized and crucial analytical tool in pharmaceutical research and development. In the manufacturing sector, however, its use is more limited despite the pivotal role that NMR can occupy in tackling issues related to quality control (QC) and troubleshooting. By means of examples, this article envisages, on the one hand, showing the nonspecialist the straightforward contribution and simplification strength of NMR analysis to aspects of their work and, on the other hand, to invite NMR spectroscopists to extend their technique and skills to the manufacturing sector. As QC applications, the article discusses among others the identification and quantitation of peptides (an alternative to the classical amino acid analysis) and of complex carbohydrates by NMR spectroscopy. Emphasis is given to the lack of elaborate sample preparation protocols, to the robustness, and to the economy brought by NMR spectroscopy, making it an ideal QC technique. In troubleshooting-related examples, it is stressed how a close inspection of a simple and fast H-1 NMR analysis, recorded without extensive method development, can lead to the detection, identification, and quantitation of unexpected unknowns, i.e., helping to find of the root cause of the investigated problem.