{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T19:17:00Z","timestamp":1789154220188,"version":"build-2803163510"},"reference-count":31,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T00:00:00Z","timestamp":1761955200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmaceutical and Biomedical Analysis"],"published-print":{"date-parts":[[2025,11]]},"DOI":"10.1016\/j.jpba.2025.117006","type":"journal-article","created":{"date-parts":[[2025,6,2]],"date-time":"2025-06-02T02:38:39Z","timestamp":1748831919000},"page":"117006","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":1,"special_numbering":"C","title":["Identification of related substances in letrozole using LC-Q-TOF\/MS"],"prefix":"10.1016","volume":"265","author":[{"given":"Zhao-liang","family":"Hu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen-yu","family":"Zou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peng-wei","family":"Hu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ke-ran","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia-ying","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jie","family":"Deng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ju-cui","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min","family":"Song","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu-ting","family":"Lu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3057-4705","authenticated-orcid":false,"given":"Tai-jun","family":"Hang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"9","key":"10.1016\/j.jpba.2025.117006_bib1","doi-asserted-by":"crossref","first-page":"540","DOI":"10.1016\/j.biopha.2007.08.011","article-title":"Aromatase inhibitor and bone","volume":"61","author":"Miki","year":"2007","journal-title":"Biomed. Pharm."},{"issue":"4","key":"10.1016\/j.jpba.2025.117006_bib2","doi-asserted-by":"crossref","first-page":"411","DOI":"10.1002\/cac2.12649","article-title":"A prospective, phase II, neoadjuvant study based on chemotherapy sensitivity in HR+\u2009\/HER2- breast cancer-FINEST study","volume":"45","author":"Chen","year":"2025","journal-title":"Cancer Commun."},{"issue":"1","key":"10.1016\/j.jpba.2025.117006_bib3","doi-asserted-by":"crossref","DOI":"10.1016\/j.rbmo.2024.104296","article-title":"Characteristics of polycystic ovary syndrome rat models induced by letrozole, testosterone propionate and high-fat diets","volume":"50","author":"Hu","year":"2025","journal-title":"Reprod. BioMed. Online"},{"issue":"4","key":"10.1016\/j.jpba.2025.117006_bib4","doi-asserted-by":"crossref","first-page":"627","DOI":"10.1136\/ijgc-2023-005189","article-title":"A phase II, multicenter, open-label study of abemaciclib and letrozole in patients with estrogen receptor-positive rare ovarian cancer: ALEPRO trial","volume":"34","author":"Ottenbourgs","year":"2024","journal-title":"Int. J. Gynecol. Cancer"},{"issue":"3","key":"10.1016\/j.jpba.2025.117006_bib5","doi-asserted-by":"crossref","first-page":"599","DOI":"10.1200\/JCO.22.00628","article-title":"A phase II, two-stage study of letrozole and abemaciclib in estrogen receptor-positive recurrent endometrial cancer","volume":"41","author":"Konstantinopoulos","year":"2023","journal-title":"J. Clin. Oncol."},{"issue":"1-2","key":"10.1016\/j.jpba.2025.117006_bib6","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.2025.117006_bib7","unstructured":"Chinese Pharmacopoeia Commission, Pharmacopoeia of the People\u2019s Republic of China, China Medical Science and Technology Press, Beijing, 2020."},{"key":"10.1016\/j.jpba.2025.117006_bib8","unstructured":"British Pharmacopoeia Commission, British Pharmacopoeia 2024, Medicines and Healthcare products Regulatory Agency, London, 2024."},{"key":"10.1016\/j.jpba.2025.117006_bib9","unstructured":"European Pharmacopoeia Committee, European Pharmacopoeia, 11.0 ed, European Directorate for the Quality of Medicines & HealthCare, France, 2022."},{"key":"10.1016\/j.jpba.2025.117006_bib10","unstructured":"The United States Pharmacopieial Convention, USP 47-NF 42, The United States Pharmacopeial Convention, Rockville, MD, 2024."},{"key":"10.1016\/j.jpba.2025.117006_bib11","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpba.2024.116085","article-title":"Impurity assessment, development and validation of an RP-HPLC method for the determination of eleven potential impurities of eltrombopag precursor","volume":"243","author":"Demirhan","year":"2024","journal-title":"J. Pharm. Biomed. Anal."},{"issue":"19","key":"10.1016\/j.jpba.2025.117006_bib12","doi-asserted-by":"crossref","first-page":"3750","DOI":"10.1080\/10408398.2021.1993128","article-title":"LC-Q-TOF-MS\/MS detection of food flavonoids: principle, methodology, and applications","volume":"63","author":"Yang","year":"2023","journal-title":"Crit. Rev. Food Sci. Nutr."},{"issue":"Pt B","key":"10.1016\/j.jpba.2025.117006_bib13","article-title":"Isolation and identification of 17\u03b2-estradiol degrading bacteria and its degradation pathway","volume":"423","author":"Zhang","year":"2022","journal-title":"J. Hazard. Mater."},{"issue":"5","key":"10.1016\/j.jpba.2025.117006_bib14","doi-asserted-by":"crossref","first-page":"962","DOI":"10.1016\/j.jpba.2011.08.022","article-title":"Determination and characterization of degradation products of anastrozole by LC-MS\/MS and NMR spectroscopy","volume":"56","author":"Sitaram","year":"2011","journal-title":"J. Pharm. Biomed. Anal."},{"issue":"05","key":"10.1016\/j.jpba.2025.117006_bib15","first-page":"367","article-title":"Improved synthesis of antitumor drug letrozole","volume":"27","author":"Zhou","year":"2017","journal-title":"Chin. J. Med. Chem."},{"issue":"05","key":"10.1016\/j.jpba.2025.117006_bib16","first-page":"56","article-title":"Study on the synthesis of letrozole","volume":"41","author":"Xu","year":"2015","journal-title":"Anhui Chem. Ind."},{"key":"10.1016\/j.jpba.2025.117006_bib17","first-page":"85","article-title":"Study on the synthesis of letrozole","volume":"04","author":"Zhou","year":"2003","journal-title":"J. China Pharm. Univ."},{"issue":"02","key":"10.1016\/j.jpba.2025.117006_bib18","first-page":"41","article-title":"Improved synthesis of breast cancer drug letrozole","volume":"15","author":"Lu","year":"2017","journal-title":"Chin. J. Bioprocess Eng."},{"key":"10.1016\/j.jpba.2025.117006_bib19","unstructured":"International Council for Harmonisation (ICH) Guideline, Q1A (R2) Stability Testing of New Drug Substances and Products, International Council for Harmonisation, Geneva, Switzerland, 2003."},{"key":"10.1016\/j.jpba.2025.117006_bib20","unstructured":"International Council for Harmonisation (ICH) Guideline, Q1B Stability Testing: Photostability Testing of New Drug Substances and Products, International Council for Harmonisation, Geneva, Switzerland, 1996."},{"key":"10.1016\/j.jpba.2025.117006_bib21","unstructured":"International Council for Harmonisation (ICH) Guideline, M7(R2): Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, International Council for Harmonisation, Geneva, Switzerland, 2023."},{"key":"10.1016\/j.jpba.2025.117006_bib22","unstructured":"International Council for Harmonisation (ICH) Guideline, Q2 (R2): Validation of Analytical Procedures, International Council for Harmonisation, Geneva, Switzerland, 2023."},{"key":"10.1016\/j.jpba.2025.117006_bib23","doi-asserted-by":"crossref","first-page":"63","DOI":"10.1016\/j.biteb.2019.02.007","article-title":"1H-1,2,4-Triazole biodegradation by newly isolated Raoultella sp.: a novel biodegradation pathway","volume":"6","author":"Liu","year":"2019","journal-title":"Bioresour. Technol. Rep."},{"issue":"1","key":"10.1016\/j.jpba.2025.117006_bib24","article-title":"Persulfate activation by Fe3O4-doped biochar synthesized from Fenton sludge and sewage sludge for enhanced 1-H-1,2,4-triazole degradation","volume":"461","author":"Tong","year":"2023","journal-title":"Chem. Eng. J."},{"issue":"1","key":"10.1016\/j.jpba.2025.117006_bib25","doi-asserted-by":"crossref","first-page":"534","DOI":"10.1021\/acs.joc.3c02284","article-title":"Aerobic benzylic C(sp(3))-H bond oxygenations catalyzed by NBS under visible light irradiation","volume":"89","author":"Ye","year":"2024","journal-title":"J. Org. Chem."},{"issue":"1","key":"10.1016\/j.jpba.2025.117006_bib26","doi-asserted-by":"crossref","DOI":"10.1016\/j.jece.2024.114977","article-title":"Degradation of toluene via DBD: detailed kinetic reaction mechanism","volume":"13","author":"Cui","year":"2025","journal-title":"J. Environ. Chem. Eng."},{"issue":"2","key":"10.1016\/j.jpba.2025.117006_bib27","first-page":"146","article-title":"Application of gas chromatography-high resolution quadrupole time of flight mass spectrometry to the analysis of benzaldehyde, benzyl alcohol acetophenone and phenylacetaldehyde in complex aromatic samples","volume":"33","author":"Liu","year":"2015","journal-title":"Se Pu"},{"issue":"23","key":"10.1016\/j.jpba.2025.117006_bib28","doi-asserted-by":"crossref","first-page":"4161","DOI":"10.1016\/0006-2952(86)90690-8","article-title":"The formation and metabolism of N-hydroxymethyl compounds--IX. N-(acetoxymethyl)-4-chlorobenzamide: an electrophile but not a mutagen in Salmonella typhimurium","volume":"35","author":"Overton","year":"1986","journal-title":"Biochem. Pharm."},{"issue":"1-2","key":"10.1016\/j.jpba.2025.117006_bib29","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1016\/0165-1218(85)90003-5","article-title":"Chloracetamide-N-metholol: an example of an in vitro and in vivo clastogen which is non-mutagenic to Salmonella","volume":"156","author":"Ashby","year":"1985","journal-title":"Mutat. Res."},{"issue":"21","key":"10.1016\/j.jpba.2025.117006_bib30","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1002\/em.2850190603","article-title":"Salmonella mutagenicity tests: V. Results from the testing of 311 chemicals","volume":"19","author":"Zeiger","year":"1992","journal-title":"Environ. Mol. Mutagen"},{"issue":"2-3","key":"10.1016\/j.jpba.2025.117006_bib31","doi-asserted-by":"crossref","first-page":"71","DOI":"10.1016\/0165-7992(84)90045-9","article-title":"Lack of mutagenicity to S. typhimurium of neopentyl bromide and pentaerythrityl tetrachloride: relation to chemical structure","volume":"140","author":"Ashby","year":"1984","journal-title":"Mutat. Res."}],"container-title":["Journal of Pharmaceutical and Biomedical Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0731708525003474?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0731708525003474?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,8,13]],"date-time":"2025-08-13T11:29:53Z","timestamp":1755084593000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0731708525003474"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11]]},"references-count":31,"alternative-id":["S0731708525003474"],"URL":"https:\/\/doi.org\/10.1016\/j.jpba.2025.117006","relation":{},"ISSN":["0731-7085"],"issn-type":[{"value":"0731-7085","type":"print"}],"subject":[],"published":{"date-parts":[[2025,11]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Identification of related substances in letrozole using LC-Q-TOF\/MS","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.2025.117006","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":"117006"}}