ArticleAnalytical biochemistry2011
Mass balance analysis of contaminated heparin product.
Article in Analytical biochemistry, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
4 citing papers in PubMed.
- Method to detect contaminants in heparin using radical depolymerization and liquid chromatography-mass spectrometry.Analytical chemistry · 2014Article
- Profiling glycol-split heparins by high-performance liquid chromatography/mass spectrometry analysis of their heparinase-generated oligosaccharides.Analytical biochemistry · 2013Article
- Structural characterization of heparins from different commercial sources.Analytical and bioanalytical chemistry · 2011Article
- Competitive inhibition of heparinase by persulfonated glycosaminoglycans: a tool to detect heparin contamination.Analytical chemistry · 2011Article
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
A 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).
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Registered trials
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