1D and 2D-HSQC NMR: two methods to distinguish and characterize heparin from different animal and tissue sources
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Authors
Mauri, Lucio
Marinozzi, Maria
Phatak, Nisarga
Karfunkle, Michael
St. Ange, Kalib
Guerrini, Marco
Keire, David A.
Linhardt, Robert J.
Issue Date
2019-06-27
Type
Article
Language
ENG
Keywords
Biology , Chemistry and chemical biology , Chemical and biological engineering , Biomedical engineering
Alternative Title
Abstract
The US Food and Drug Administration has encouraged the reintroduction of bovine heparin drug product to the US market to mitigate the risks of heparin shortages and potential adulteration or contamination of the primary source which is porcine heparin. Here, a 1D-NMR method was applied to compare heparin sodium of bovine intestinal origin with that of bovine lung, porcine, or ovine intestinal origin. The results showed that a simple 1D test using NMR signal intensity ratios among diagnostic signals of the proton spectra uniquely identified the origin of heparin and concomitantly could be used to assure the correct sample labeling. However, a limitation of the use of only mono-dimensional spectra is that these spectra may not provide sufficiently detailed information on the composition of heparin batches to adequately determine the quality of this complex product. As an alternative, a higher resolution quantitative 2D-HSQC method was used to calculate the percentage of mono- and disaccharides, distinguish the origin of heparin and, simultaneously, assess the heparin composition. The 2D-HSQC method is proposed to provide sufficient information to evaluate the quality of industrial production process used to make the drug substance. Together, the 1D and 2D data produced by these measurements can be used to assure the identity and purity of this widely used drug.
Description
Frontiers in Medicine, 6, 1-9
Note : if this item contains full text it may be a preprint, author manuscript, or a Gold OA copy that permits redistribution with a license such as CC BY. The final version is available through the publisher’s platform.
Note : if this item contains full text it may be a preprint, author manuscript, or a Gold OA copy that permits redistribution with a license such as CC BY. The final version is available through the publisher’s platform.
Full Citation
1D and 2D-HSQC NMR: two methods to distinguish and characterize heparin from different animal and tissue sources, L. Mauri, M. Marinozzi, N. Phatak, M. Karfunkle, K. StAnge, M. Guerrini, D. Keire, R. J. Linhardt, Frontiers in Medicine, 6, 1-9, 2019.
Publisher
Frontiers Media SA
Terms of Use
Journal
Volume
Issue
PubMed ID
DOI
ISSN
2296858X