Analysis and characterization of heparin impurities

Anal Bioanal Chem. 2011 Jan;399(2):527-39. doi: 10.1007/s00216-010-4121-x. Epub 2010 Sep 3.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Review

MeSH terms

  • Animals
  • Anticoagulants / chemistry*
  • Anticoagulants / isolation & purification
  • Chondroitin Sulfates / analysis
  • Chondroitin Sulfates / chemistry
  • Chromatography, High Pressure Liquid / methods
  • Drug Contamination*
  • Electrophoresis / methods
  • Heparin / chemistry*
  • Heparin / isolation & purification
  • Humans
  • Magnetic Resonance Spectroscopy / methods
  • Spectroscopy, Near-Infrared / methods
  • Spectrum Analysis, Raman / methods

Substances

  • Anticoagulants
  • Heparin
  • Chondroitin Sulfates