{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T23:06:53Z","timestamp":1778972813098,"version":"3.51.4"},"reference-count":34,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T00:00:00Z","timestamp":1777420800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100008769","name":"University of W\u00fcrzburg","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100008769","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":[[2026,9]]},"DOI":"10.1016\/j.jpba.2026.117542","type":"journal-article","created":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T09:39:46Z","timestamp":1777541986000},"page":"117542","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["Degradation study of thiamine hydrochloride and analysis of expired ampoules using a novel, validated HPLC-UV method"],"prefix":"10.1016","volume":"278","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5700-2902","authenticated-orcid":false,"given":"Sylvia","family":"Klapper","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0364-7278","authenticated-orcid":false,"given":"Ulrike","family":"Holzgrabe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.jpba.2026.117542_bib1","doi-asserted-by":"crossref","first-page":"3326","DOI":"10.1038\/s41598-024-53280-0","article-title":"Undernutrition in children under five associated with wealth-related inequality in 24 low- and middle-income countries from 2017 to 2022","volume":"14","author":"Birhanu","year":"2024","journal-title":"Sci. Rep."},{"key":"10.1016\/j.jpba.2026.117542_bib2","series-title":"Mutschler Arzneimittelwirkungen: Pharmakologie, klinische Pharmakologie, Toxikologie","author":"Geisslinger","year":"2020"},{"key":"10.1016\/j.jpba.2026.117542_bib3","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1111\/nyas.13919","article-title":"Thiamine deficiency disorders: diagnosis, prevalence, and a roadmap for global control programs","volume":"1430","author":"Whitfield","year":"2018","journal-title":"Ann. N. Y. Acad. Sci."},{"key":"10.1016\/j.jpba.2026.117542_bib4","series-title":"ICH Topic Q 1 A (R2): Stability Testing of new Drug Substances and Products","author":"European Medicines Agency","year":"2003"},{"key":"10.1016\/j.jpba.2026.117542_bib5","doi-asserted-by":"crossref","first-page":"1331","DOI":"10.1002\/jps.23925","article-title":"United States food and drug administration and department of defense shelf-life extension program of pharmaceutical products: progress and promise","volume":"103","author":"Khan","year":"2014","journal-title":"J. Pharm. Sci."},{"key":"10.1016\/j.jpba.2026.117542_bib6","doi-asserted-by":"crossref","first-page":"222","DOI":"10.1016\/j.jpba.2019.01.016","article-title":"A systematic review of the stability of finished pharmaceutical products and drug substances beyond their labeled expiry dates","volume":"166","author":"Zilker","year":"2019","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.jpba.2026.117542_bib7","doi-asserted-by":"crossref","first-page":"1685","DOI":"10.1001\/archinternmed.2012.4501","article-title":"Stability of active ingredients in long-expired prescription medications","volume":"172","author":"Cantrell","year":"2012","journal-title":"Arch. Intern. Med."},{"key":"10.1016\/j.jpba.2026.117542_bib8","doi-asserted-by":"crossref","first-page":"1154","DOI":"10.1055\/s-0028-1121660","article-title":"Praktische Erfahrungen mit dem Vitaminpr\u00e4parat Betaxin","volume":"63","author":"Ebermaier","year":"1937","journal-title":"Dtsch. Med. Woche"},{"key":"10.1016\/j.jpba.2026.117542_bib9","series-title":"Die Therapie an den Berliner Universit\u00e4ts-Kliniken","year":"1949"},{"key":"10.1016\/j.jpba.2026.117542_bib10","unstructured":"Bracco, Betabion, Betabion 'forte', Betabion 'fortissimum'. \u3008https:\/\/www.archiviostoricobracco.com\/en\/oggetti\/1126-betabion-betabion-forte-betabion-fortissimum?i=4\u3009, 2026 (accessed February 19, 2026)."},{"key":"10.1016\/j.jpba.2026.117542_bib11","unstructured":"Roche Deutschland Holding GmbH, Roche Meilensteine -1952. \u3008https:\/\/www.roche.de\/unternehmen\/wer-wir-sind\/unsere-geschichte\/unternehmenshistorie#dbe44781-f9e6-4e81-93b8-8425e9505377\u3009, 2026 (accessed February 19, 2026)."},{"key":"10.1016\/j.jpba.2026.117542_bib12","doi-asserted-by":"crossref","first-page":"54","DOI":"10.1021\/jf60185a004","article-title":"Chemistry of thiamine degradation on food products and model systems. Review","volume":"21","author":"Dwivedi","year":"1973","journal-title":"J. Agric. Food Chem."},{"key":"10.1016\/j.jpba.2026.117542_bib13","doi-asserted-by":"crossref","first-page":"354","DOI":"10.1002\/jps.2600510415","article-title":"Kinetics of thiamine hydrolysis","volume":"51","author":"Windheuser","year":"1962","journal-title":"J. Pharm. Sci."},{"key":"10.1016\/j.jpba.2026.117542_bib14","doi-asserted-by":"crossref","first-page":"443","DOI":"10.1016\/j.foodres.2018.06.056","article-title":"Chemical stability and reaction kinetics of two thiamine salts (thiamine mononitrate and thiamine chloride hydrochloride) in solution","volume":"112","author":"Voelker","year":"2018","journal-title":"Food Res. Int."},{"key":"10.1016\/j.jpba.2026.117542_bib15","first-page":"111","article-title":"Kinetische Untersuchungen \u00fcber Wechselwirkungen und Abbaureaktionen wasserl\u00f6slicher Vitamine. Teil 3: Thiamin","volume":"24","author":"H\u00fcttenrauch","year":"1969","journal-title":"Pharmazie"},{"key":"10.1016\/j.jpba.2026.117542_bib16","doi-asserted-by":"crossref","first-page":"495","DOI":"10.1111\/j.1749-6632.1962.tb30570.x","article-title":"A Tricyclic form of thiamine","volume":"98","author":"Metzler","year":"1962","journal-title":"Ann. N. Y. Acad. Sci."},{"key":"10.1016\/j.jpba.2026.117542_bib17","doi-asserted-by":"crossref","first-page":"2335","DOI":"10.1021\/ja00346a037","article-title":"Kinetics and thermodynamics of the structural transformations of thiamine in neutral and basic aqueous media. The UV spectrum of the tetrahedral pseudobase intermediate","volume":"105","author":"El Hage Chahine","year":"1983","journal-title":"J. Am. Chem. Soc."},{"key":"10.1016\/j.jpba.2026.117542_bib18","doi-asserted-by":"crossref","first-page":"463","DOI":"10.1039\/p29950000463","article-title":"Hydrolysis of thiamine","volume":"2","author":"Herrmann","year":"1995","journal-title":"J. Chem. Soc. Perkin Trans."},{"key":"10.1016\/j.jpba.2026.117542_bib19","doi-asserted-by":"crossref","first-page":"492","DOI":"10.1038\/nchembio.2007.13","article-title":"A new thiamin salvage pathway","volume":"3","author":"Jenkins","year":"2007","journal-title":"Nat. Chem. Biol."},{"key":"10.1016\/j.jpba.2026.117542_bib20","doi-asserted-by":"crossref","first-page":"381","DOI":"10.1016\/0308-8146(92)90272-4","article-title":"The effect of xylose on the generation of volatiles from heated thiamine","volume":"44","author":"Hincelin","year":"1992","journal-title":"Food Chem."},{"key":"10.1016\/j.jpba.2026.117542_bib21","doi-asserted-by":"crossref","DOI":"10.1111\/j.1365-2621.2005.tb11463.x","article-title":"Kinetics of thiamin degradation in solutions under ambient storage conditions","volume":"70","author":"Pachapurkar","year":"2005","journal-title":"J. Food Sci."},{"key":"10.1016\/j.jpba.2026.117542_bib22","doi-asserted-by":"crossref","first-page":"47","DOI":"10.1186\/s13065-021-00773-y","article-title":"Effect of pH and concentration on the chemical stability and reaction kinetics of thiamine mononitrate and thiamine chloride hydrochloride in solution","volume":"15","author":"Voelker","year":"2021","journal-title":"BMC Chem."},{"key":"10.1016\/j.jpba.2026.117542_bib23","doi-asserted-by":"crossref","first-page":"1911","DOI":"10.1093\/ajhp\/38.12.1911","article-title":"Thiamine destruction by sodium bisulfite in infusion solutions","volume":"38","author":"Scheiner","year":"1981","journal-title":"Am. J. Health-Syst. Pharm."},{"key":"10.1016\/j.jpba.2026.117542_bib24","doi-asserted-by":"crossref","first-page":"547","DOI":"10.1016\/S0899-9007(97)00034-8","article-title":"Stability of ranitidine and thiamine in parenteral nutrition solutions","volume":"13","author":"Baumgartner","year":"1997","journal-title":"Nutrition"},{"key":"10.1016\/j.jpba.2026.117542_bib25","doi-asserted-by":"crossref","first-page":"1317","DOI":"10.1021\/ja01236a033","article-title":"Thiamin Stability. Effect of Amino Acids and Related Compounds and of Thiamin Concentration","volume":"66","author":"McIntire","year":"1944","journal-title":"J. Am. Chem. Soc."},{"key":"10.1016\/j.jpba.2026.117542_bib26","doi-asserted-by":"crossref","first-page":"557","DOI":"10.1002\/jps.2600520609","article-title":"Effect of Various Compounds on the Rate of Thiamine Hydrolysis","volume":"52","author":"Windheuser","year":"1963","journal-title":"J. Pharm. Sci."},{"key":"10.1016\/j.jpba.2026.117542_bib27","series-title":"Council of Europe, European Pharmacopoeia","year":"2022"},{"key":"10.1016\/j.jpba.2026.117542_bib28","series-title":"United States Pharmacopeia 45 \u2013 National Formulary 40","author":"United States Pharmacopeial Convention","year":"2022"},{"key":"10.1016\/j.jpba.2026.117542_bib29","series-title":"ICH Q2(R2) Guideline on validation of analytical procedures","author":"European Medicines Agency","year":"2024"},{"key":"10.1016\/j.jpba.2026.117542_bib30","doi-asserted-by":"crossref","first-page":"151","DOI":"10.22159\/ijap.2020v12i6.38283","article-title":"Impurity profiling impurity profiling of thiamine hydrochloride injection by rp-hplc and characterization of degradation product by LC-MS\/MS\/QTOF","author":"Kondra","year":"2020","journal-title":"Int. J. Appl. Pharm."},{"key":"10.1016\/j.jpba.2026.117542_bib31","doi-asserted-by":"crossref","first-page":"808","DOI":"10.1002\/hlca.19670500307","article-title":"Die Massenspektren von Vitamin B1 und von einigen Modellverbindungen 6. Mitteilung \u00fcber das massenspektrometrische verhalten quart\u00e4rer Stickstoffverbindungen","volume":"50","author":"Hesse","year":"1967","journal-title":"Helv. Chim. Acta"},{"key":"10.1016\/j.jpba.2026.117542_bib32","doi-asserted-by":"crossref","first-page":"2632","DOI":"10.1021\/bi00579a031","article-title":"Biosynthesis of the pyrimidine moiety of thiamin in Escherichia coli: incorporation of stable isotope-labeled glycines","volume":"18","author":"White","year":"1979","journal-title":"Biochemistry"},{"key":"10.1016\/j.jpba.2026.117542_bib33","doi-asserted-by":"crossref","first-page":"381","DOI":"10.1007\/s10895-021-02861-7","article-title":"Fluorometric assessment of sulfhydryl oxidase activity: optimization by response surface methodology","volume":"32","author":"Hadwan","year":"2022","journal-title":"J. Fluor."},{"key":"10.1016\/j.jpba.2026.117542_bib34","doi-asserted-by":"crossref","first-page":"1335","DOI":"10.1016\/S0278-6915(02)00107-2","article-title":"Evaluation of the health aspects of methyl paraben: a review of the published literature","volume":"40","author":"Soni","year":"2002","journal-title":"Food Chem. Toxicol."}],"container-title":["Journal of Pharmaceutical and Biomedical Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0731708526002104?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0731708526002104?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T22:19:35Z","timestamp":1778969975000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0731708526002104"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9]]},"references-count":34,"alternative-id":["S0731708526002104"],"URL":"https:\/\/doi.org\/10.1016\/j.jpba.2026.117542","relation":{},"ISSN":["0731-7085"],"issn-type":[{"value":"0731-7085","type":"print"}],"subject":[],"published":{"date-parts":[[2026,9]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Degradation study of thiamine hydrochloride and analysis of expired ampoules using a novel, validated HPLC-UV method","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.2026.117542","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 The Authors. Published by Elsevier B.V.","name":"copyright","label":"Copyright"}],"article-number":"117542"}}