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dc.contributor.authorLiu, Zhenling
dc.contributor.authorXiao, Zhongping
dc.contributor.authorMasuko, Sayaka
dc.contributor.authorZhao, Wenjing
dc.contributor.authorSterner, Eric
dc.contributor.authorBansal, Vinod
dc.contributor.authorFareed, Jawed
dc.contributor.authorDordick, Jonathan
dc.contributor.authorZhang, Fuming
dc.contributor.authorLinhardt Robert J., R. J.
dc.date2011
dc.date.accessioned2022-06-23T04:08:41Z
dc.date.available2022-06-23T04:08:41Z
dc.date.issued2011-01-01
dc.identifier.citationMass balance analysis of contaminated heparin product, Z. Liu, Z. Xiao, S. Masuko, W. Zhao, E. Sterner, V. Bansal, J. Fareed, J. S. Dordick, F. Zhang, R. J. Linhardt, Analytical Biochemistry, 408, 147-156, 2011.
dc.identifier.issn10960309
dc.identifier.issn32697
dc.identifier.urihttps://hdl.handle.net/20.500.13015/5245
dc.identifier.urihttps://doi.org/10.1016/j.ab.2010.09.015
dc.descriptionAnalytical Biochemistry, 408, 147-156
dc.descriptionNote : 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.
dc.description.abstractA quantitative analysis of a recalled contaminated lot of heparin sodium injection U.S. Pharmacopeia (USP) was undertaken in response to the controversy regarding the exact nature of the contaminant involved in the heparin (HP) crisis. A mass balance analysis of the formulated drug product was performed. After freeze-drying, a 1-ml vial for injection afforded 54.8±0.3 mg of dry solids. The excipients, sodium chloride and residual benzyl alcohol, accounted for 11.4±0.5 and 0.9±0.5 mg, respectively. Active pharmaceutical ingredient (API) represented 41.5±1.0 mg, corresponding to 75.7 wt% of dry mass. Exhaustive treatment of API with specific enzymes, heparin lyases, and/or chondroitin lyases was used to close mass balance. HP represented 30.5±0.5 mg, corresponding to 73.5 wt% of the API. Dermatan sulfate (DS) impurity represented 1.7±0.3 mg, corresponding to 4.1 wt% of API. Contaminant, representing 9.3±0.1 mg corresponding to 22.4 wt% of API, was found in the contaminated formulated drug product. The recovery of contaminant was close to quantitative (95.6-100 wt%). A single contaminant was unambiguously identified as oversulfated chondroitin sulfate (OSCS).
dc.description.sponsorshipNational Institutes of Health
dc.languageen_US
dc.language.isoENG
dc.publisherElsevier
dc.relation.ispartofThe Linhardt Research Labs Online Collection
dc.relation.ispartofRensselaer Polytechnic Institute, Troy, NY
dc.relation.ispartofAnalytical Biochemistry
dc.relation.urihttps://harc.rpi.edu/
dc.subjectBiology
dc.subjectChemistry and chemical biology
dc.subjectChemical and biological engineering
dc.subjectBiomedical engineering
dc.titleMass balance analysis of contaminated heparin product
dc.typeArticle
dcterms.accessRightsA full text version is available in DSpace@RPI
dcterms.isPartOfJournal
dcterms.isVersionOfhttps://doi.org/10.1016/j.ab.2010.09.015
dc.rights.holderIn Copyright : this Item is protected by copyright and/or related rights. You are free to use this Item in any way that is permitted by the copyright and related rights legislation that applies to your use. For other uses you need to obtain permission from the rights-holder(s). https://rightsstatements.org/page/InC/1.0/
dc.creator.identifierhttps://orcid.org/0000-0003-2219-5833
dc.relation.departmentThe Linhardt Research Labs.
dc.relation.departmentThe Shirley Ann Jackson, Ph.D. Center for Biotechnology and Interdisciplinary Studies (CBIS)
rpi.description.pages147-156
rpi.description.volume408


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