By Akshar Gupta
Quantitative NMR (qNMR) spectroscopy is a technique used for assay determination without the need for a chemically identical reference standard. The intensity of the resonance lines in an NMR spectrum are directly proportional only to the quantity of their resonant nuclei and is independent of their chemical environment. The robustness and ease in acquiring qNMR spectra make this method highly desirable as an orthogonal tool for purity determination by chromatographic separation. In this poster we summarize the application of our qNMR analytical method for assay determination of pharmaceutical materials including starting materials, intermediates, drug substances, drug products, and excipients. These principles are applied across 1H, 19F, and 31P nuclei using appropriate parameters selected carefully under controlled instrument conditions. Assay results are used to support the organization across various functions and key phases throughout chemical development and are found to be robust among multiple analysts. With over 2,000 experiments collected to date using this method, our data show that qNMR can be effectively implemented and executed by non-expert analysts without compromising the quality of results.