Solid-state NMR utility in pharmaceutical process development

ANYL 221

Robert Wenslow Jr., robert_wenslow@merck.com, CMSE (Center for Material Science and Engineering), Merck & Co., Inc, 125 E. Lincoln Ave, Rahway, NJ 07065
Characterization of the physical form of solid drug substances or drug product is a critical issue in pharmaceutical development. Solid-state nuclear magnetic resonance (SSNMR) can readily distinguish and differentiate between polymorph and pseudo-polymorph forms of many pharmaceutical compounds. This session will present the application of routine solid-state NMR spectroscopy towards characterization during both API and formulation process development. Topics include: (1)Polymorph form identification and quantitation, (2)solvate identification and characterization, (3)multiple solid phase detection through relaxation methods, (4)characterizing complex polymorph systems, and (5)detection and quantitation of amorphous formation during processing.