Differentiation of Generic Enoxaparins Marketed in the United States by Employing NMR and Multivariate Analysis Journal Article


Authors: Guerrini, M.; Rudd, T. R.; Mauri, L.; Macchi, E.; Fareed, J; Yates, E. A.; Naggi, A.; Torri, G.
Article Title: Differentiation of Generic Enoxaparins Marketed in the United States by Employing NMR and Multivariate Analysis
Abstract: The U.S. Food and Drug Administration defines criteria for the equivalence of Enoxaparin with Lovenox, comprising the equivalence of physiochemical properties, heparin source material and mode of depolymerization, disaccharide building blocks, fragment mapping and sequence of oligosaccharide species, biological and biochemical assays, and in vivo pharmacodynamic profile. Chemometric analysis of the NMR spectra, utilizing both (1)H and (1)H-(13)C HSQC NMR experiments, of Lovenox and Enoxaparin, the latter being the generic version of the former, revealed that Lovenox and the four Enoxaparin compounds produced by Sandoz (Enoxaparin and Fibrinox), Winthrop, and Amphastar exhibit dissimilarities in terms of their composition. All of the collected samples had expiry dates between 2012 and 2015. These studies, in addition to chromatographic analysis, highlighted signatures that differentiated the branded material from the generic products.
Journal Title: Analytical Chemistry
Volume: 87
Issue: 16
ISSN: 1520-6882; 0003-2700
Publisher: Unknown  
Journal Place: United States
Date Published: 2015
Start Page: 8275
End Page: 8283
Language: eng
DOI/URL:
Notes: JID: 0370536; 2015/08/06 [aheadofprint]; ppublish