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

DOI: 10.1021/acs.analchem.5b01366 DOI Help

Authors: Marco Guerrini (Istituto di Ricerche Chimiche e Biochimiche) , Timothy R. Rudd (Diamond Light Source) , Lucio Mauri (Istituto di Ricerche Chimiche e Biochimiche “G. Ronzoni”) , Eleonora Macchi (Istituto di Ricerche Chimiche e Biochimiche “G. Ronzoni”) , Jawed Fareed (Loyola University Medical Center) , Edwin Yates (University of Liverpool) , Annamaria Naggi (Istituto di Ricerche Chimiche e Biochimiche “G. Ronzoni”) , Giangiacomo Torri (Istituto di Ricerche Chimiche e Biochimiche “G. Ronzoni”)
Co-authored by industrial partner: No

Type: Journal Paper
Journal: Analytical Chemistry , VOL 87 , PAGES 8275 - 8283

State: Published (Approved)
Published: August 2015

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 1H and 1H–13C 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.

Subject Areas: Chemistry


Technical Areas: