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Tools for the Quality Control of Pharmaceutical Heparin.

Devlin, A; Mycroft-West, C; Procter, P; Cooper, L; Guimond, S; Andrade De Lima, M; Yates, E; Skidmore, M

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A Devlin

C Mycroft-West

P Procter

L Cooper

E Yates


Heparin is a vital pharmaceutical anticoagulant drug and remains one of the few naturally sourced pharmaceutical agents used clinically. Heparin possesses a structural order with up to four levels of complexity. These levels are subject to change based on the animal or even tissue sources that they are extracted from, while higher levels are believed to be entirely dynamic and a product of their surrounding environments, including bound proteins and associated cations. In 2008, heparin sources were subject to a major contamination with a deadly compound-an over-sulphated chondroitin sulphate polysaccharide-that resulted in excess of 100 deaths within North America alone. In consideration of this, an arsenal of methods to screen for heparin contamination have been applied, based primarily on the detection of over-sulphated chondroitin sulphate. The targeted nature of these screening methods, for this specific contaminant, may leave contamination by other entities poorly protected against, but novel approaches, including library-based chemometric analysis in concert with a variety of spectroscopic methods, could be of great importance in combating future, potential threats.


Devlin, A., Mycroft-West, C., Procter, P., Cooper, L., Guimond, S., Andrade De Lima, M., …Skidmore, M. (2019). Tools for the Quality Control of Pharmaceutical Heparin. Medicina, 55, 636 - 636.

Journal Article Type Article
Acceptance Date Sep 4, 2019
Publication Date Sep 25, 2019
Publicly Available Date May 26, 2023
Journal Medicina (Kaunas)
Print ISSN 0025-7729
Electronic ISSN 1648-9144
Publisher MDPI
Volume 55
Pages 636 - 636
Keywords analysis, chemometrics, glycosaminoglycans, heparin, quality control, spectroscopic methods, Animals, Chondroitin Sulfates, Chromatography, High Pressure Liquid, Drug Contamination, Heparin, Humans, Magnetic Resonance Spectroscopy, Pharmaceutical Preparat
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