Different Analytical Approaches to the Characterization of Non-Biological Complex Drugs

Arthuer Komlosh, Teva Pharmaceutical Industries , Kfar Saba, Israel (Turi.Komlosh@tevausa.com)

Non-biological Complex Drugs (NBCDs) are pharmaceutical compounds that are highly complex synthetic mixtures that are usually composed of closely related molecular structures. For that reason characterization of NBCDs presented great analytical challenges that cannot be achieved by traditional analytical methods.  As part of an ongoing effort to better characterize Copaxone (which is a NBCD) a number of new analytical methods were developed.  These orthogonal methods provided better understanding of the physiochemical nature of Copaxone.