USP compendial methods for analysis of heparin: chromatographic determination of molecular weight distributions for heparin sodium
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216_2014_Article_7940.pdf
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Author(s)
Mulloy, Barbara
Heath, Alan
Jameison, Fabian
Al Hakim, Ali
Morris, Tina S.
Szajek, Anita Y.
Shriver, Zachary H
Date Issued
June 2014
Journal
Analytical and Bioanalytical Chemistry
Publisher
Springer Berlin Heidelberg
Citation
Mulloy, Barbara et al. “USP Compendial Methods for Analysis of Heparin: Chromatographic Determination of Molecular Weight Distributions for Heparin Sodium.” Analytical and Bioanalytical Chemistry 406.20 (2014): 4815–4823.
Version
Author's final manuscript
Abstract
Heparin is a polysaccharide product isolated from glycosaminoglycans of porcine mucosa (or occasionally other tissues and species). It is a linear non-uniform polymer consisting of alternating glucosamine and uronic acid monosaccharide residues and is highly sulfated. Heparin sodium drug product (HP) used in medicine consists of chains with molecular weight (MW) ranging from under 5,000 to over 50,000. Although HP has been used as an injectable antithrombotic medicine for more than 70 years, many aspects of its structure and purity, including its MW, have not been specified by public standards until recent years. In 2008, a number of HP lots associated with severe adverse effects, including fatalities, were found to have been contaminated with oversulfated chondroitin sulfate. This incident led to thorough revision of compendial standards worldwide. In the USA, the Food and Drug Administration (FDA) encouraged the inclusion of enhanced standards for purity and identity in the relevant monographs of the United States Pharmacopeia (USP) including acceptance criteria for MW distribution.
MIT Department
Massachusetts Institute of Technology. Department of Biological Engineering
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Article is made available in accordance with the publisher's policy and may be subject to US copyright law. Please refer to the publisher's site for terms of use.
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DOI of Published Version
https://doi.org/10.1007/s00216-014-7940-3
