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Analysis of Heparin Samples by Attenuated Total Reflectance Fourier-Transform Infrared Spectroscopy in the Solid
Anthony J Devlin1,2, Courtney J Mycroft-West1,3, Jeremy E Turnbull1
1Centre for Glycoscience Research and Training, Keele University, Huxley Building, Keele, Staffordshire ST5 5BG, United Kingdom.
ACS Central Science
|March 27, 2023
Summary
A new method using attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR) offers rapid, cost-effective quality control for pharmaceutical heparin. This technique ensures heparin safety by detecting contaminants, complementing existing methods.
Area of Science:
- Analytical Chemistry
- Biochemistry
- Pharmacology
Background:
- Pharmaceutical heparin, a glycosaminoglycan (GAG), is a critical anticoagulant and an essential medicine.
- The 2008 heparin contamination crisis highlighted the inadequacy of existing quality control methods, necessitating improved analytical techniques.
- Multidimensional nuclear magnetic resonance (NMR) spectroscopy with multivariate analysis became the gold standard but is technically demanding and costly.
Purpose of the Study:
- To develop and validate an alternative, cost-effective, and rapid method for monitoring pharmaceutical heparin quality.
- To assess the capability of attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR) combined with multivariate analysis for GAG analysis.
- To ensure the safety and efficacy of pharmaceutical heparin by detecting adulterants and verifying species provenance.
Main Methods:
- Utilized attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR) coupled with multivariate analysis.
- Applied the developed methodology to differentiate diverse GAG samples and classify samples by species origin.
- Evaluated the method's sensitivity and ability to detect contaminants like oversulfated chondroitin sulfate (OSCS).
Main Results:
- The ATR-FTIR method successfully differentiated various GAG samples and identified their species provenance.
- The technique demonstrated high sensitivity, comparable to multidimensional NMR spectroscopy.
- Established heparin contaminants and alien polysaccharides were effectively detected, confirming the method's reliability.
Conclusions:
- ATR-FTIR combined with multivariate analysis provides a rapid, cost-effective, and sensitive alternative for pharmaceutical heparin quality control.
- This methodology is suitable for widespread deployment throughout the heparin supply chain, enhancing safety and regulatory compliance.
- The developed approach addresses the limitations of current methods, offering a practical solution for preventing future contamination events.
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