{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T04:32:36Z","timestamp":1791433956171,"version":"4.3.3"},"reference-count":50,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,12,1]],"date-time":"2026-12-01T00:00:00Z","timestamp":1796083200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,12,1]],"date-time":"2026-12-01T00:00:00Z","timestamp":1796083200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T00:00:00Z","timestamp":1790035200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000015","name":"U.S. Department of Energy","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000015","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006229","name":"Oak Ridge Institute for Science and Education","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006229","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmaceutical and Biomedical Analysis"],"published-print":{"date-parts":[[2026,12]]},"DOI":"10.1016\/j.jpba.2026.117680","type":"journal-article","created":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T15:16:23Z","timestamp":1785338183000},"page":"117680","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":1,"special_numbering":"C","title":["Solvent compatibility for extractables analysis of silicones"],"prefix":"10.1016","volume":"281","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-8421-6367","authenticated-orcid":false,"given":"Md Shah","family":"Alam","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0189-6668","authenticated-orcid":false,"given":"Kanti","family":"Sapkota","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7019-1779","authenticated-orcid":false,"given":"Jacob","family":"Hill","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"4","key":"10.1016\/j.jpba.2026.117680_bib1","doi-asserted-by":"crossref","first-page":"217","DOI":"10.1055\/s-0039-1696985","article-title":"The evolution of breast implants","volume":"33","author":"Kaoutzanis","year":"2019","journal-title":"Semin. Plast. Surg."},{"key":"10.1016\/j.jpba.2026.117680_bib2","doi-asserted-by":"crossref","first-page":"166","DOI":"10.1016\/j.jpra.2022.02.004","article-title":"History of breast implants: back to the future","volume":"32","author":"Santanelli di Pompeo","year":"2022","journal-title":"JPRAS Open."},{"key":"10.1016\/j.jpba.2026.117680_bib3","doi-asserted-by":"crossref","first-page":"48","DOI":"10.1016\/j.aca.2012.05.004","article-title":"Applications of polydimethylsiloxane in analytical chemistry: a review","volume":"750","author":"Seethapathy","year":"2012","journal-title":"Anal. Chim. Acta"},{"issue":"38","key":"10.1016\/j.jpba.2026.117680_bib4","doi-asserted-by":"crossref","first-page":"50969","DOI":"10.1002\/app.50969","article-title":"Silicone-based biomaterials for biomedical applications: antimicrobial strategies and 3D printing technologies","volume":"138","author":"Zare","year":"2021","journal-title":"J. Appl. Polym. Sci."},{"issue":"7","key":"10.1016\/j.jpba.2026.117680_bib5","doi-asserted-by":"crossref","first-page":"491","DOI":"10.1021\/ar010110q","article-title":"Poly(dimethylsiloxane) as a material for fabricating microfluidic devices","volume":"35","author":"McDonald","year":"2002","journal-title":"Acc. Chem. Res."},{"issue":"1","key":"10.1016\/j.jpba.2026.117680_bib6","doi-asserted-by":"crossref","first-page":"2","DOI":"10.3390\/jfb13010002","article-title":"Properties and applications of PDMS for biomedical engineering: a review","volume":"13","author":"Miranda","year":"2021","journal-title":"J. Funct. Biomater."},{"key":"10.1016\/j.jpba.2026.117680_bib7","first-page":"2861","article-title":"Beyond PDMS and membranes: new materials for organ-on-a-chip devices","author":"Radisic","year":"2021","journal-title":"ACS Pub"},{"issue":"23","key":"10.1016\/j.jpba.2026.117680_bib8","doi-asserted-by":"crossref","first-page":"6544","DOI":"10.1021\/ac0346712","article-title":"Solvent compatibility of poly (dimethylsiloxane)-based microfluidic devices","volume":"75","author":"Lee","year":"2003","journal-title":"Anal. Chem."},{"issue":"9","key":"10.1016\/j.jpba.2026.117680_bib9","doi-asserted-by":"crossref","first-page":"1338","DOI":"10.1248\/cpb.c16-00322","article-title":"Evaluation of a silicone membrane as an alternative to human skin for determining skin permeation parameters of chemical compounds","volume":"64","author":"Uchida","year":"2016","journal-title":"Chem. Pharm. Bull."},{"key":"10.1016\/j.jpba.2026.117680_bib10","unstructured":"(ISO) ISO. 10993\u201318: 2020 Biological evaluation of medical devices-Part 18: Chemical characterization of medical device materials within a risk management process. International Organization for Standardization (ISO): Geneva, Switzerland2020."},{"key":"10.1016\/j.jpba.2026.117680_bib11","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpba.2024.115985","article-title":"Identification and quantification of medical device extractables and leachables via non-target analysis (NTA); Analytical uncertainty","volume":"241","author":"Jenke","year":"2024","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.jpba.2026.117680_bib12","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpba.2024.116215","article-title":"Development and application of a protocol for extractables profiling from central venous catheters in neonates","volume":"246","author":"Le Basle","year":"2024","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.jpba.2026.117680_bib13","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpba.2022.115142","article-title":"Exploring three-dimensional space of extractables and leachables in volatility, hydrophobicity, and molecular weight and assessment of roles of gas and liquid chromatographic methods in their comprehensive analysis","volume":"223","author":"Li","year":"2023","journal-title":"J. Pharm. Biomed. Anal."},{"issue":"4","key":"10.1016\/j.jpba.2026.117680_bib14","doi-asserted-by":"crossref","first-page":"645","DOI":"10.1351\/pac199971040645","article-title":"Critical compilation of scales of solvent parameters. Part I. Pure, non-hydrogen bond donor solvents","volume":"71","author":"Abboud","year":"1999","journal-title":"Pure Appl. Chem."},{"key":"10.1016\/j.jpba.2026.117680_bib15","doi-asserted-by":"crossref","first-page":"600","DOI":"10.1016\/j.memsci.2015.04.063","article-title":"Solubility and diffusivity of liquids for food and pharmaceutical applications in crosslinked polydimethylsiloxane (PDMS) films: I. Experimental data on pure organic components and vegetable oil","volume":"492","author":"Cocchi","year":"2015","journal-title":"J. Membr. Sci."},{"issue":"1-2","key":"10.1016\/j.jpba.2026.117680_bib16","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1016\/j.ijpharm.2006.02.011","article-title":"Extractables\/leachables from plastic tubing used in product manufacturing","volume":"315","author":"Jenke","year":"2006","journal-title":"Int. J. Pharm."},{"key":"10.1016\/j.jpba.2026.117680_bib17","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpba.2022.115081","article-title":"A systematic analysis of the effect of extraction solvents on the chemical composition of extraction solutions and the analytical implications in extractables and leachables studies","volume":"222","author":"Li","year":"2023","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.jpba.2026.117680_bib18","doi-asserted-by":"crossref","DOI":"10.1016\/j.foodchem.2020.128964","article-title":"Influence of cooking conditions on the migration of silicone oligomers from silicone rubber baking molds to food simulants","volume":"347","author":"Liu","year":"2021","journal-title":"Food Chem."},{"issue":"21","key":"10.1016\/j.jpba.2026.117680_bib19","doi-asserted-by":"crossref","first-page":"2999","DOI":"10.1002\/cphc.201700408","article-title":"Revisiting Hansen solubility parameters by including thermodynamics","volume":"18","author":"Louwerse","year":"2017","journal-title":"Chem. Phys. Chem."},{"issue":"6","key":"10.1016\/j.jpba.2026.117680_bib20","doi-asserted-by":"crossref","first-page":"2455","DOI":"10.1002\/jbm.b.34052","article-title":"Solvent or thermal extraction of ethylene oxide from polymeric materials: Medical device considerations","volume":"106","author":"Lucas","year":"2018","journal-title":"J. Biomed. Mater. Res. Part. B Appl. Biomater."},{"key":"10.1016\/j.jpba.2026.117680_bib21","doi-asserted-by":"crossref","DOI":"10.3389\/fphar.2016.00132","article-title":"Direct human contact with siloxanes (silicones)\u2013safety or risk part 1. Characteristics of siloxanes (silicones)","volume":"7","author":"Mojsiewicz-Pie\u0144kowska","year":"2016","journal-title":"Front. Pharmacol."},{"issue":"2","key":"10.1016\/j.jpba.2026.117680_bib22","doi-asserted-by":"crossref","first-page":"223","DOI":"10.1016\/S0021-9673(00)85732-5","article-title":"Classification of the solvent properties of common liquids","volume":"92","author":"Snyder","year":"1974","journal-title":"J. Chromatogr. A."},{"issue":"10","key":"10.1016\/j.jpba.2026.117680_bib23","doi-asserted-by":"crossref","first-page":"4188","DOI":"10.1021\/acs.jcim.9b00656","article-title":"Critical Assessment of the Hildebrand and Hansen Solubility Parameters for Polymers","volume":"59","author":"Venkatram","year":"2019","journal-title":"J. Chem. Inform. Model."},{"issue":"2","key":"10.1016\/j.jpba.2026.117680_bib24","doi-asserted-by":"crossref","first-page":"472","DOI":"10.1021\/acs.jced.3c00406","article-title":"Solvent Diffusion Modeling in Silicone","volume":"69","author":"Wagner","year":"2023","journal-title":"J. Chem. Eng. Data"},{"issue":"12","key":"10.1016\/j.jpba.2026.117680_bib25","doi-asserted-by":"crossref","first-page":"2069","DOI":"10.1002\/(SICI)1097-4628(19961219)62:12<2069::AID-APP10>3.0.CO;2-1","article-title":"Critical analysis of the graphical determination of Hansen's solubility parameters for lightly crosslinked polymers","volume":"62","author":"Zellers","year":"1996","journal-title":"J. Appl. Polym. Sci."},{"issue":"163","key":"10.1016\/j.jpba.2026.117680_bib26","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1002\/pol.1962.1205616315","article-title":"The swelling of polymer systems in solvents. II. Mathematics of diffusion","volume":"56","author":"Buckley","year":"1962","journal-title":"J. Polym. Sci."},{"key":"10.1016\/j.jpba.2026.117680_bib27","doi-asserted-by":"crossref","DOI":"10.1016\/j.polymertesting.2019.106253","article-title":"Effect of crosslink density on solubility parameters of styrene butadiene rubber and the application in pre-screening of new potential additives","volume":"81","author":"Chu","year":"2020","journal-title":"Polym. Test."},{"issue":"1","key":"10.1016\/j.jpba.2026.117680_bib28","first-page":"2","article-title":"The universality of the solubility parameter","volume":"8","author":"Hansen","year":"1969","journal-title":"Ind. Eng. Chem Prod. Res. Dev."},{"issue":"7","key":"10.1016\/j.jpba.2026.117680_bib29","doi-asserted-by":"crossref","first-page":"1202","DOI":"10.1021\/ie50559a034","article-title":"Swelling of silicone elastomers","volume":"48","author":"Hauser","year":"1956","journal-title":"Ind. Eng. Chem."},{"key":"10.1016\/j.jpba.2026.117680_bib30","doi-asserted-by":"crossref","DOI":"10.1016\/j.foodcont.2021.108354","article-title":"Swelling as a promoter of migration of plastic additives in the interaction of fatty food simulants with polylactic acid-and polypropylene-based plastics","volume":"132","author":"Kirchkeszner","year":"2022","journal-title":"Food Control."},{"issue":"6","key":"10.1016\/j.jpba.2026.117680_bib31","doi-asserted-by":"crossref","first-page":"1592","DOI":"10.1021\/acs.jpca.7b12128","article-title":"Influence of solvent swelling on ultrafast structural dynamics in polydimethylsiloxane thin films by two-dimensional IR spectroscopy","volume":"122","author":"Olson","year":"2018","journal-title":"J. Phys. Chem. A."},{"issue":"10","key":"10.1016\/j.jpba.2026.117680_bib32","doi-asserted-by":"crossref","first-page":"4503","DOI":"10.1016\/j.eurpolymj.2007.07.012","article-title":"The effect of polymer swelling and resistance to flow on solvent diffusion and permeability","volume":"43","author":"Zhu","year":"2007","journal-title":"Eur. Polym. J."},{"issue":"6","key":"10.1016\/j.jpba.2026.117680_bib33","doi-asserted-by":"crossref","first-page":"443","DOI":"10.1016\/j.medengphy.2004.12.013","article-title":"Materials for urinary catheters: a review of their history and development in the UK","volume":"27","author":"Lawrence","year":"2005","journal-title":"Med. Eng. Phys."},{"issue":"8","key":"10.1016\/j.jpba.2026.117680_bib34","doi-asserted-by":"crossref","first-page":"1311","DOI":"10.1080\/19440049.2012.684891","article-title":"Determination of siloxanes in silicone products and potential migration to milk, formula and liquid simulants","volume":"29","author":"Zhang","year":"2012","journal-title":"Food Addit. Contam. Part. A."},{"key":"10.1016\/j.jpba.2026.117680_bib35","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1016\/j.memsci.2015.09.014","article-title":"Solvent dependent solute solubility governs retention in silicone based organic solvent nanofiltration","volume":"497","author":"Postel","year":"2016","journal-title":"J. Membr. Sci."},{"issue":"39","key":"10.1016\/j.jpba.2026.117680_bib36","doi-asserted-by":"crossref","first-page":"10091","DOI":"10.1039\/C5TC01927C","article-title":"Swelling of PDMS networks in solvent vapours; applications for passive RFID wireless sensors","volume":"3","author":"Rumens","year":"2015","journal-title":"J. Mater. Chem. C."},{"issue":"5","key":"10.1016\/j.jpba.2026.117680_bib37","doi-asserted-by":"crossref","first-page":"1059","DOI":"10.1016\/j.jpba.2004.03.025","article-title":"Analysis of low-molar-mass materials in commercial rubber samples by Soxhlet and headspace extractions followed by GC\u2013MS analysis","volume":"35","author":"Delaunay-Bertoncini","year":"2004","journal-title":"J. Pharm. Biomed. Anal."},{"issue":"7","key":"10.1016\/j.jpba.2026.117680_bib38","doi-asserted-by":"crossref","first-page":"7275","DOI":"10.1126\/sciadv.abe7275","article-title":"Like dissolves like: a first-principles theory for predicting liquid miscibility and mixture dielectric constant","volume":"7","author":"Zhuang","year":"2021","journal-title":"Sci. Adv."},{"key":"10.1016\/j.jpba.2026.117680_bib39","unstructured":"U.S. Food and Drug Administration. Saline, Silicone Gel, and Alternative Breast Implants: Guidance for Industry and Food and Drug Administration Staff. (2020)."},{"key":"10.1016\/j.jpba.2026.117680_bib40","series-title":"Hansen Solubility Parameters: A User's Handbook, Second Edition","author":"Hansen","year":"2007"},{"issue":"8","key":"10.1016\/j.jpba.2026.117680_bib41","doi-asserted-by":"crossref","first-page":"1482","DOI":"10.1021\/ja01299a049","article-title":"Polarization and Dielectric Constant of Liquids","volume":"58","author":"Wyman","year":"1936","journal-title":"J. Am. Chem. Soc."},{"issue":"21","key":"10.1016\/j.jpba.2026.117680_bib42","doi-asserted-by":"crossref","first-page":"7077","DOI":"10.1021\/acs.iecr.7b04940","article-title":"Theoretical and practical considerations when selecting solvents for use in extractables studies of polymeric contact materials in single-use systems applied in the production of biopharmaceuticals","volume":"57","author":"Dorey","year":"2018","journal-title":"Ind. Eng. Chem. Res."},{"issue":"8","key":"10.1016\/j.jpba.2026.117680_bib43","doi-asserted-by":"crossref","first-page":"2319","DOI":"10.1021\/cr00032a005","article-title":"Solvatochromic dyes as solvent polarity indicators","volume":"94","author":"Reichardt","year":"1994","journal-title":"Chem. Rev."},{"issue":"11","key":"10.1016\/j.jpba.2026.117680_bib44","doi-asserted-by":"crossref","first-page":"1673","DOI":"10.1002\/app.1994.070541111","article-title":"Use of empirical polarity parameters to describe polymer\/liquid interactions: Correlation of polymer swelling with solvent polarity in binary and ternary systems","volume":"54","author":"Jonqui\u00e8res","year":"1994","journal-title":"J. Appl. Polym. Sci."},{"issue":"22","key":"10.1016\/j.jpba.2026.117680_bib45","doi-asserted-by":"crossref","first-page":"4383","DOI":"10.1016\/S0040-4020(02)00417-9","article-title":"Solvation of polymers as model for solvent effect investigation: proposition of a novel polarity scale","volume":"58","author":"Malavolta","year":"2002","journal-title":"Tetrahedron"},{"key":"10.1016\/j.jpba.2026.117680_bib46","unstructured":"U.S. Food and Drug Administration. Saline, Silicone Gel, and Alternative Breast Implants: Guidance for Industry and Food and Drug Administration Staff. www.fda.gov2020."},{"issue":"35","key":"10.1016\/j.jpba.2026.117680_bib47","doi-asserted-by":"crossref","first-page":"11242","DOI":"10.1002\/anie.201805206","article-title":"Multiphase-assembly of siloxane oligomers with improved mechanical strength and water-enhanced healing","volume":"57","author":"Liu","year":"2018","journal-title":"Angew. Chem. Int. Ed."},{"issue":"1","key":"10.1016\/j.jpba.2026.117680_bib48","doi-asserted-by":"crossref","first-page":"205","DOI":"10.1023\/A:1010196214867","article-title":"Glass and structural transitions measured at polymer surfaces on the nanoscale","volume":"59","author":"Overney","year":"2000","journal-title":"J. Therm. Anal. Calorim."},{"key":"10.1016\/j.jpba.2026.117680_bib49","first-page":"423","article-title":"Chemisorption and physisorption of polymer nanocomposite membranes","volume":"11","author":"Namakka","year":"2025"},{"issue":"1","key":"10.1016\/j.jpba.2026.117680_bib50","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1039\/D2EM00386D","article-title":"Assessing and managing environmental hazards of polymers: historical development, science advances and policy options","volume":"25","author":"Groh","year":"2023","journal-title":"Environ. Sci. Process. Impacts"}],"container-title":["Journal of Pharmaceutical and Biomedical Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0731708526003481?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0731708526003481?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T21:45:30Z","timestamp":1790113530000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0731708526003481"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,12]]},"references-count":50,"alternative-id":["S0731708526003481"],"URL":"https:\/\/doi.org\/10.1016\/j.jpba.2026.117680","relation":{},"ISSN":["0731-7085"],"issn-type":[{"value":"0731-7085","type":"print"}],"subject":[],"published":{"date-parts":[[2026,12]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Solvent compatibility for extractables analysis of silicones","name":"articletitle","label":"Article Title"},{"value":"Journal of Pharmaceutical and Biomedical Analysis","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jpba.2026.117680","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"Published by Elsevier B.V.","name":"copyright","label":"Copyright"}],"article-number":"117680"}}