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Analysis of Heparin Samples by Attenuated Total Reflectance Fourier-Transform Infrared Spectroscopy in the Solid State.

Devlin, Anthony J; Mycroft-West, Courtney J; Turnbull, Jeremy E; Andrade De Lima, Marcelo; Guerrini, Marco; Yates, Edwin A; Skidmore, Mark A

Analysis of Heparin Samples by Attenuated Total Reflectance Fourier-Transform Infrared Spectroscopy in the Solid State. Thumbnail


Authors

Anthony J Devlin

Courtney J Mycroft-West

Marco Guerrini

Edwin A Yates



Abstract

Heparin is a polydisperse, heterogeneous polysaccharide of the glycosaminoglycan (GAG) class that has found widespread clinical use as a potent anticoagulant and is classified as an essential medicine by the World Health Organization. The importance of rigorous monitoring and quality control of pharmaceutical heparin was highlighted in 2008, when the existing regulatory procedures failed to identify a life-threatening adulteration of pharmaceutical heparin with oversulfated chondroitin sulfate (OSCS). The subsequent contamination crisis resulted in the exploration of alternative approaches for which the use of multidimensional nuclear magnetic resonance (NMR) spectroscopy techniques and multivariate analysis emerged as the gold standard. This procedure is, however, technically demanding and requires access to expensive equipment. An alternative approach, utilizing attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR) combined with multivariate analysis, has been developed. The method described enables the differentiation of diverse GAG samples, the classification of samples of distinct species provenance, and the detection of both established heparin contaminants and alien polysaccharides. This methodology has sensitivity comparable to that of NMR and can facilitate the rapid, cost-effective monitoring and analysis of pharmaceutical heparin. It is therefore suitable for future deployment throughout the supply chain.

Citation

Devlin, A. J., Mycroft-West, C. J., Turnbull, J. E., Andrade De Lima, M., Guerrini, M., Yates, E. A., & Skidmore, M. A. (2023). Analysis of Heparin Samples by Attenuated Total Reflectance Fourier-Transform Infrared Spectroscopy in the Solid State. ACS Central Science, 9, 381-392. https://doi.org/10.1021/acscentsci.2c01176

Journal Article Type Article
Acceptance Date Feb 14, 2023
Online Publication Date Feb 14, 2023
Publication Date 2023-02
Publicly Available Date May 30, 2023
Journal ACS Central Science
Print ISSN 2374-7943
Publisher American Chemical Society
Volume 9
Pages 381-392
DOI https://doi.org/10.1021/acscentsci.2c01176
Publisher URL https://pubs.acs.org/doi/10.1021/acscentsci.2c01176

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