Analysis and characterization of heparin impurities.
This review discusses recent developments in analytical methods available for the sensitive separation, detection and structural characterization of heparin contaminants. The adulteration of raw heparin with oversulfated chondroitin sulfate (OSCS) in 2007-2008 spawned a global crisis resulting in extensive revisions to the pharmacopeia monographs on heparin and prompting the FDA to recommend the development of additional physicochemical methods for the analysis of heparin purity. The analytical chemistry community quickly responded to this challenge, developing a wide variety of innovative approaches, several of which are reported in this special issue. This review provides an overview of methods of heparin isolation and digestion, discusses known heparin contaminants, including OSCS, and summarizes recent publications on heparin impurity analysis using sensors, near-IR, Raman, and NMR spectroscopy, as well as electrophoretic and chromatographic separations.
Beni
Szabolcs
S
Department of Chemistry, University of California, Riverside, CA 92521, USA.
Limtiaco
John F K
JF
Larive
Cynthia K
CK
D000818:Animals; D000925:Anticoagulants / Q000737:chemistry* / Q000302:isolation & purification; D002809:Chondroitin Sulfates / Q000032:analysis / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004340:Drug Contamination; D004586:Electrophoresis / Q000379:methods; D006493:Heparin / Q000737:chemistry* / Q000302:isolation & purification; D006801:Humans; D009682:Magnetic Resonance Spectroscopy / Q000379:methods; D019265:Spectroscopy, Near-Infrared / Q000379:methods; D013059:Spectrum Analysis, Raman / Q000379:methods
D000925:Anticoagulants; D006493:Heparin; D002809:Chondroitin Sulfates
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