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Pentosan Polysulfate Sodium Profiling with Ion Mobility Mass Spectrometry


EMSL Project ID
51133

Abstract

Pentosan polysulfate sodium, known as PPS, is the active pharmaceutical ingredient in the prescription drug Elmiron, and is indicated for interstitial cystitis, a painful bladder condition caused by deterioration of the epithelial lining of the bladder. PPS is a heterogeneous mixture of sulfated glucuronoxylan polysaccharides produced through chemical modification of beechwood hemicellulose. Physicochemical characterization and profiling of this mixture is important for determining similarity and bioequivalence for generic forms of the PPS drug substance. We have previously developed an approach for profiling PPS using drift tube ion mobility mass spectrometry and NMR spectroscopy. In this proposal, we will adapt this approach to traveling wave ion mobility MS, and make measurements for PPS drug substance samples from different manufacturers, as well as for PPS and/or its metabolites that have been extracted from urine. The results will be used in our statistical methodology for determination of macromolecular similarity.

Project Details

Start Date
2019-10-15
End Date
2020-09-30
Status
Closed

Team

Principal Investigator

John Cort
Institution
Pacific Northwest National Laboratory

Team Members

Zhangyang Xu
Institution
Pacific Northwest National Laboratory