Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug ProductsMaria Victoria Silva Elipe 1, Lan Li 1, Karthik Nagapudi 2, Alan M. Kook 3, Carlos Cobas 4, Isaac Iglesias 4, Chen Peng 4
1Department of Attribute Sciences, Amgen, Inc., 2Small Molecule Pharmaceutical Sciences, Genentech, Inc., 3NMR Service + Consulting, 4Mestrelab Research
A simple and non-destructive technique that measures the average content of drug substances in formulated drug products containing fluorine using low-field fluorine-19 (19F) time-domain (TD) nuclear magnetic resonance (NMR) is presented here. The technique can be applied to the development and manufacturing of drugs in the pharmaceutical industry.
