Document Detail

Quality assessment of unfractionated heparin using 1H nuclear magnetic resonance spectroscopy.
MedLine Citation:
PMID:  18678460     Owner:  NLM     Status:  MEDLINE    
Due to problems, especially anaphylactoid reactions, raised by impure unfractionated heparin the quality assessment of heparin has to be reconsidered. Neither the USP nor the European Pharmacopoeia are able to guarantee the purity of heparin, i.e., the limitation of oversulfated chondroitin sulfate (OSCS) which was found to be the reason for the allergic adverse effects. In the first run the regulatory authorities ask for 1H NMR spectroscopic and capillary electrophoretic measurements in order to characterize the impurity profile of heparin. Using an optimized 1H NMR method the limit of detection for OSCS was found to be 0.1%. In addition, it is possible to reliably quantify both OSCS and dermatan sulfate (DS), the latter being an indicator of poor purification of the unfractionated heparin. Screening of more than 100 heparin samples collected from international markets revealed a high number of samples containing substantial amounts of DS and a number of samples containing OSCS in an amount higher than 0.1%.
T Beyer; B Diehl; G Randel; E Humpfer; H Schäfer; M Spraul; C Schollmayer; U Holzgrabe
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2008-07-03
Journal Detail:
Title:  Journal of pharmaceutical and biomedical analysis     Volume:  48     ISSN:  0731-7085     ISO Abbreviation:  J Pharm Biomed Anal     Publication Date:  2008 Sep 
Date Detail:
Created Date:  2008-08-26     Completed Date:  2008-11-26     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8309336     Medline TA:  J Pharm Biomed Anal     Country:  England    
Other Details:
Languages:  eng     Pagination:  13-9     Citation Subset:  IM    
Institute of Pharmacy and Food Chemistry, University of Würzburg, Am Hubland, 97074 Würzburg, Germany.
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MeSH Terms
Anticoagulants / analysis*,  chemistry
Chondroitin Sulfates / chemistry
Dermatan Sulfate / chemistry
Heparin, Low-Molecular-Weight / analysis*,  chemistry
Magnetic Resonance Spectroscopy*
Molecular Structure
Reg. No./Substance:
0/Anticoagulants; 0/Heparin, Low-Molecular-Weight; 24967-94-0/Dermatan Sulfate; 9007-28-7/Chondroitin Sulfates

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