Draft Guidance on Pentosan Polysulfate Sodium. https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020193.pdf: US Food and Drug Administration; Accessed 15 Jan 2023.

Keire DA, Buhse LF, Al-Hakim A. Characterization of currently marketed heparin products: composition analysis by 2D-NMR. Anal Methods. 2013;5(12):2984–94.

Article  CAS  Google Scholar 

Lee S, Raw A, Yu L, Lionberger R, Ya N, Verthelyi D, et al. Scientific considerations in the review and approval of generic enoxaparin in the United States. Nat Biotechnol. 2013;31(3):220–6.

Article  CAS  PubMed  Google Scholar 

Ye H, Toby TK, Sommers CD, Ghasriani H, Trehy ML, Ye W, et al. Characterization of currently marketed heparin products: key tests for LMWH quality assurance. J Pharm Biomed Anal. 2013;85:99–107.

Article  CAS  PubMed  Google Scholar 

Gucinski AC, Boyne MT, Keire DA. Modern analytics for naturally derived complex drug substances: NMR and MS tests for protamine sulfate from chum salmon. Anal Bioanal Chem. 2015;407(3):749–59.

Article  CAS  PubMed  Google Scholar 

Rogstad S, Pang E, Sommers C, Hu M, Jiang X, Keire DA, et al. Modern analytics for synthetically derived complex drug substances: NMR, AFFF–MALS, and MS tests for glatiramer acetate. Anal Bioanal Chem. 2015;407(29):8647–59.

Article  CAS  PubMed  Google Scholar 

Ghasriani H, Hodgson DJ, Brinson RG, McEwen I, Buhse LF, Kozlowski S, et al. Precision and robustness of 2D-NMR for structure assessment of filgrastim biosimilars. Nat Biotechnol. 2016;34(2):139–41.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Guerrini M, Rudd TR, Mauri L, Macchi E, Fareed J, Yates EA, et al. Differentiation of generic enoxaparins marketed in the United States by employing NMR and multivariate analysis. Anal Chem. 2015;87(16):8275–83.

Article  CAS  PubMed  Google Scholar 

Lin L, Yu Y, Zhang F, Xia K, Zhang X, Linhardt RJ. Bottom-up and top-down profiling of pentosan polysulfate. Analyst. 2019;144(16):4781–6.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Mauri L, Marinozzi M, Mazzini G, Kolinski RE, Karfunkle M, Keire DA, et al. Combining NMR spectroscopy and chemometrics to monitor structural features of crude heparin. Molecules. 2017;22(7):1146.

Article  PubMed  PubMed Central  Google Scholar 

Patil SM, Li V, Peng J, Kozak D, Xu J, Cai B, et al. A simple and noninvasive DOSY NMR method for droplet size measurement of intact oil-in-water emulsion drug products. J Pharm Sci. 2019;108(2):815–20.

Article  CAS  PubMed  Google Scholar 

Patil SM, Qin B, Wang Y, Ahmed S, Yilmaz H, Jiang X, et al. A real-time NMR method for measurement of in vitro aggregation kinetics of degarelix drug products. AAPS PharmSciTech. 2021;22(2):73.

Article  CAS  PubMed  Google Scholar 

Peng J, Patil SM, Keire DA, Chen K. Chemical structure and composition of major glycans covalently linked to therapeutic monoclonal antibodies by middle-down nuclear magnetic resonance. Anal Chem. 2018;90(18):11016–24.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Suh MS, Patil SM, Kozak D, Pang E, Choi S, Jiang X, et al. An NMR protocol for in vitro paclitaxel release from an albumin-bound nanoparticle formulation. AAPS PharmSciTech. 2020;21(5):136.

Article  CAS  PubMed  Google Scholar 

Wang D, Park JH, Zheng J, Cai B, Keire DA, Chen K. Multiphase drug distribution and exchange in oil-in-water nanoemulsion revealed by high-resolution 19F qNMR. Mol Pharm. 2022;19(7):2142–50.

Article  CAS  PubMed  Google Scholar 

Wang D, Zhuo Y, Karfunkle M, Patil SM, Smith CJ, Keire DA, et al. NMR spectroscopy for protein higher order structure similarity assessment in formulated drug products. Molecules. 2021;26(14):4251.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Wang K, Chen K. Direct assessment of oligomerization of chemically modified peptides and proteins in formulations using DLS and DOSY-NMR. Pharm Res. 2023. https://doi.org/10.1007/s11095-022-03468-8.

Wang X, Patil SM, Keire DA, Xu X, Chen K. Application of ultra-centrifugation and bench-top 19F NMR for measuring drug phase partitioning for the ophthalmic oil-in-water emulsion products. AAPS PharmSciTech. 2018;19(4):1647–51.

Article  CAS  PubMed  Google Scholar 

Zhuo Y, Keire DA, Chen K. Minor N-glycan mapping of monoclonal antibody therapeutics using middle-down NMR spectroscopy. Mol Pharm. 2021;18(1):441–50.

Article  CAS  PubMed  Google Scholar 

Chen K. 2D NMR peak profiling to compare chemical differences between batches of pentosan polysulfate sodium. J Pharmaceut Biomed. 2022;211: 114589.

Article  CAS  Google Scholar 

ELMIRON®-100 MG (PENTOSAN POLYSULFATE SODIUM) CAPSULES PRESCRIBING INFORMATION. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020193Orig1s015lbl.pdf: US Food and Drug Administration; Accessed 11 Dec 2022.

Alekseeva A, Raman R, Eisele G, Clark T, Fisher A, Lee S, et al. In-depth structural characterization of pentosan polysulfate sodium complex drug using orthogonal analytical tools. Carbohyd Polym. 2020;234: 115913.

Article  CAS  Google Scholar 

De Ferra L, Naggi A, Zenoni M, Pinto B, Method for the qualification of preparations of pentosan polysulfate, raw materials and production processes thereof (US20160002365A1) patent US20160002365A1. 2016.

Mills R. Self-diffusion in normal and heavy water in the range 1–45.deg. J Phys Chem. 1973;77(5):685–8.

Article  CAS  Google Scholar 

Gabriel L, Günther W, Pielenz F, Heinze T. Determination of the binding situation of pyridine in xylan sulfates by means of detailed NMR studies. Macromol Chem Phys. 2020;221(1):1900327.

Article  CAS  Google Scholar 

Scheller HV, Ulvskov P. Hemicelluloses. Annu Rev Plant Biol. 2010;61(1):263–89.

Article  CAS  PubMed  Google Scholar 

Teleman A, Tenkanen M, Jacobs A, Dahlman O. Characterization of O-acetyl-(4-O-methylglucurono)xylan isolated from birch and beech. Carbohyd Res. 2002;337(4):373–7.

Article  CAS  Google Scholar 

Keire DA, Trehy ML, Reepmeyer JC, Kolinski RE, Ye W, Dunn J, et al. Analysis of crude heparin by 1H NMR, capillary electrophoresis, and strong-anion-exchange-HPLC for contamination by over sulfated chondroitin sulfate. J Pharm Biomed Anal. 2010;51(4):921–6.

Article  CAS  PubMed  Google Scholar