{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T21:43:56Z","timestamp":1792791836967,"version":"4.5.0"},"reference-count":20,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"funder":[{"DOI":"10.13039\/501100009330","name":"Medical Science and Technology Foundation of Guangdong Province","doi-asserted-by":"publisher","award":["A2023208"],"award-info":[{"award-number":["A2023208"]}],"id":[{"id":"10.13039\/501100009330","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100021171","name":"Basic and Applied Basic Research Foundation of Guangdong Province","doi-asserted-by":"publisher","award":["2023A1515220068"],"award-info":[{"award-number":["2023A1515220068"]}],"id":[{"id":"10.13039\/501100021171","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":[[2025,9]]},"DOI":"10.1016\/j.jpba.2025.116839","type":"journal-article","created":{"date-parts":[[2025,3,31]],"date-time":"2025-03-31T05:04:43Z","timestamp":1743397483000},"page":"116839","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":4,"special_numbering":"C","title":["Development of a novel stability-indicating UHPLC method for revefenacin quality control and impurity identification using 2D-LC-HRMS"],"prefix":"10.1016","volume":"262","author":[{"given":"Tong","family":"Zhang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Guo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunxin","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nuo","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weifeng","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lu","family":"Sun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chaoqiang","family":"Xiao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuwang","family":"He","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.jpba.2025.116839_bib1","doi-asserted-by":"crossref","first-page":"1184","DOI":"10.1093\/ajhp\/zxab154","article-title":"Revefenacin, a once-daily, long-acting muscarinic antagonist, for nebulized maintenance therapy in patients with chronic obstructive pulmonary disease","volume":"78","author":"Hvisdas","year":"2021","journal-title":"Am. J. Health Syst. Pharm."},{"key":"10.1016\/j.jpba.2025.116839_bib2","doi-asserted-by":"crossref","first-page":"38","DOI":"10.1016\/j.rmed.2019.05.010","article-title":"Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy: Safety and tolerability results of a 52-week phase 3 trial in moderate to very severe chronic obstructive pulmonary disease","volume":"153","author":"Donohue","year":"2019","journal-title":"Respir. Med."},{"key":"10.1016\/j.jpba.2025.116839_bib3","doi-asserted-by":"crossref","first-page":"77","DOI":"10.58739\/jcbs\/v08i3.8","article-title":"Revefenacin, Drug review","volume":"08","author":"Bhuvana","year":"2018","journal-title":"J. Clin. Biomed. Sci."},{"key":"10.1016\/j.jpba.2025.116839_bib4","article-title":"First global approval","volume":"79","author":"Revefenacin","year":"2018","journal-title":"Drugs"},{"key":"10.1016\/j.jpba.2025.116839_bib5","unstructured":"\u3008http:\/\/www.nhc.gov.cn\/yaozs\/s7656\/202312\/b6617e087d9a424fa2ef844c00c7cf43.shtml\u3009 (accessed on February 2025)."},{"key":"10.1016\/j.jpba.2025.116839_bib6","doi-asserted-by":"crossref","first-page":"110","DOI":"10.1016\/j.jpba.2018.07.050","article-title":"Risk-based approach for method development in pharmaceutical quality control context: a critical review","volume":"161","author":"Deidda","year":"2018","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.jpba.2025.116839_bib7","doi-asserted-by":"crossref","first-page":"95","DOI":"10.52711\/2231-5675.2024.00017","article-title":"Advancement in high-performance liquid chromatography techniques: a comprehensive review","author":"Gavit","year":"2024","journal-title":"Asian J. Pharm. Anal."},{"key":"10.1016\/j.jpba.2025.116839_bib8","first-page":"371","article-title":"UPLC: a preeminent technique in pharmaceutical analysis","volume":"69","author":"Kumar","year":"2012","journal-title":"Acta Pol. Pharm."},{"key":"10.1016\/j.jpba.2025.116839_bib9","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1186\/s13065-023-00949-8","article-title":"Exploiting the power of UPLC in separation and simultaneous determination of pholcodine, guaiacol along with three specified guaiacol impurities","volume":"17","author":"Mohamed","year":"2023","journal-title":"BMC Chem."},{"key":"10.1016\/j.jpba.2025.116839_bib10","doi-asserted-by":"crossref","first-page":"1365","DOI":"10.1007\/s10337-013-2477-8","article-title":"UPLC versus HPLC on drug analysis: advantageous, applications and their validation parameters","volume":"76","author":"Gumustas","year":"2013","journal-title":"Chromatographia"},{"key":"10.1016\/j.jpba.2025.116839_bib11","doi-asserted-by":"crossref","first-page":"580","DOI":"10.1080\/22297928.2021.1911680","article-title":"A validated stability-indicating method for separation of prucalopride drug by HPLC: Method transfer to UPLC","volume":"11","author":"Makwana","year":"2021","journal-title":"Anal. Chem. Lett."},{"key":"10.1016\/j.jpba.2025.116839_bib12","doi-asserted-by":"crossref","DOI":"10.4172\/2157-7064.1000349","article-title":"Forced degradation study an essential approach to develop stability indicating method","author":"Sharma","year":"2017","journal-title":"J. Chromatogr. Sep. Tech."},{"key":"10.1016\/j.jpba.2025.116839_bib13","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpba.2020.113309","article-title":"Development of a method of analysis for profiling of the impurities in phenoxymethylpenicillin potassium based on the analytical quality by design concept combined with the degradation mechanism of penicillins","volume":"186","author":"Du","year":"2020","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.jpba.2025.116839_bib14","doi-asserted-by":"crossref","first-page":"328","DOI":"10.1016\/j.ijpharm.2018.04.007","article-title":"Current regulatory requirements and practical approaches for stability analysis of pharmaceutical products: a comprehensive review","volume":"543","author":"SenGupta","year":"2018","journal-title":"Int. J. Pharm."},{"key":"10.1016\/j.jpba.2025.116839_bib15","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1016\/j.trac.2017.09.012","article-title":"Critical review of reports on impurity and degradation product profiling in the last decade","volume":"101","author":"G\u00f6R\u00f6G","year":"2018","journal-title":"TrAC Trends Anal. Chem."},{"key":"10.1016\/j.jpba.2025.116839_bib16","doi-asserted-by":"crossref","DOI":"10.1016\/j.chroma.2022.463632","article-title":"Application of heart-cutting two-dimensional liquid chromatography-mass spectrometry to the characterization of highly polar impurities in calcium gluconate injection","volume":"1685","author":"Gu","year":"2022","journal-title":"J. Chromatogr. A."},{"key":"10.1016\/j.jpba.2025.116839_bib17","unstructured":"ICH guideline Q1A (R2), Stability testing of new drug substances and products, International Conference on Harmonization, Geneva, Switzerland, 2003."},{"key":"10.1016\/j.jpba.2025.116839_bib18","article-title":"Considerations on the design and implementation of chemical drugs stress testing","volume":"28","author":"Gou","year":"2019","journal-title":"Chin. J. New Drugs"},{"key":"10.1016\/j.jpba.2025.116839_bib19","unstructured":"M. Li, Organic Chemistry of Drug Degradation, The Chemical Industry Press, 2019."},{"key":"10.1016\/j.jpba.2025.116839_bib20","unstructured":"ICH guideline Q2 (R1), Validation of Analytical Procedures Text and Methodology, International Conference on Harmonization, Geneva, Switzerland, 2005."}],"container-title":["Journal of Pharmaceutical and Biomedical Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0731708525001803?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0731708525001803?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,11,5]],"date-time":"2025-11-05T02:15:31Z","timestamp":1762308931000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0731708525001803"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9]]},"references-count":20,"alternative-id":["S0731708525001803"],"URL":"https:\/\/doi.org\/10.1016\/j.jpba.2025.116839","relation":{},"ISSN":["0731-7085"],"issn-type":[{"value":"0731-7085","type":"print"}],"subject":[],"published":{"date-parts":[[2025,9]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Development of a novel stability-indicating UHPLC method for revefenacin quality control and impurity identification using 2D-LC-HRMS","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.2025.116839","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 Elsevier B.V. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}],"article-number":"116839"}}