{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,17]],"date-time":"2025-10-17T00:34:57Z","timestamp":1760661297443,"version":"build-2065373602"},"reference-count":20,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,3,18]],"date-time":"2025-03-18T00:00:00Z","timestamp":1742256000000},"content-version":"vor","delay-in-days":17,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100010878","name":"State Administration for Science, Technology and Industry for National Defense","doi-asserted-by":"publisher","award":["HNKF202221(36)"],"award-info":[{"award-number":["HNKF202221(36)"]}],"id":[{"id":"10.13039\/501100010878","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Labelled Comp Radiopharmac"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>[<jats:sup>18<\/jats:sup>F]Florbetazine injection, a radiotracer that could target A\u03b2 plaques and achieve diagnosis of Alzheimer's disease (<jats:sc>AD<\/jats:sc>), is a novel positron emission tomography (PET) imaging agent currently in the investigational new drug (IND) application stage. The active ingredient of [<jats:sup>18<\/jats:sup>F]Florbetazine injection, [<jats:sup>18<\/jats:sup>F]Florbetazine, is a diaryl\u2010azine derivative. Chemical and radiochemical purity is critical quality attributes (CQAs) for [<jats:sup>18<\/jats:sup>F]Florbetazine injection, and thus, we have developed and validated a relevant HPLC method. This study describes the specificity, linearity, accuracy, repeatability, and limit of quantification (LOQ) of the HPLC method. The stability of three sample batches was investigated using the established method. The validation results demonstrated the accuracy, precision, and sensitivity of the method, making it suitable for implementation as part of the quality control (QC) process for [<jats:sup>18<\/jats:sup>F]Florbetazine injection. The stability of three sample batches revealed a decrease in concentration and radiochemical purity over 10\u2009h. However, all samples maintained a radiochemical purity of over 90% after 10\u2009h. The results provided a foundation for establishing quality standards for [<jats:sup>18<\/jats:sup>F]Florbetazine injection. The same methodology employed in this study could be applied and modified for QC protocols of other <jats:sup>18<\/jats:sup>F\u2010labeled radiopharmaceuticals.<\/jats:p>","DOI":"10.1002\/jlcr.4140","type":"journal-article","created":{"date-parts":[[2025,3,19]],"date-time":"2025-03-19T01:40:44Z","timestamp":1742348444000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development and Validation of an HPLC Method to Determine Chemical and Radiochemical Purity of [<sup>18<\/sup>F]Florbetazine Injection"],"prefix":"10.1002","volume":"68","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6983-579X","authenticated-orcid":false,"given":"Fuhai","family":"Wu","sequence":"first","affiliation":[{"name":"Department of Chemistry, College of Chemistry and Life Science, Center of Excellence for Environmental Safety and Biological Effects Beijing University of Technology  Beijing China"},{"name":"High Tech Atom Co., Ltd.  Beijing 102413 China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaoming","family":"Wang","sequence":"additional","affiliation":[{"name":"High Tech Atom Co., Ltd.  Beijing 102413 China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huan","family":"Chen","sequence":"additional","affiliation":[{"name":"High Tech Atom Co., Ltd.  Beijing 102413 China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xu","family":"Zhou","sequence":"additional","affiliation":[{"name":"High Tech Atom Co., Ltd.  Beijing 102413 China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hailong","family":"Zhao","sequence":"additional","affiliation":[{"name":"High Tech Atom Co., Ltd.  Beijing 102413 China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mengchao","family":"Cui","sequence":"additional","affiliation":[{"name":"Key Laboratory of Radiopharmaceuticals, Ministry of Education Beijing Normal University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,3,18]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12694"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.14283\/jpad.2021.23"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neurobiolaging.2022.03.001"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32205-4"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12422"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.bioconjchem.6b00444"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcmg.2020.02.023"},{"volume-title":"IAEA\u2010TECDOC\u20101856","year":"2018","author":"Quality Control in the Production of Radiopharmaceuticals","key":"e_1_2_10_9_1"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.2c01503"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00259-021-05615-6"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1515\/ract-2021-1137"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11094-020-02213-y"},{"key":"e_1_2_10_14_1","unstructured":"National Medical Products Administration \u201cTechnical Guidelines for Phase I Clinical Trial Application of New Drugs \u201d (2018) Accessed May 20 2022 https:\/\/www.nmpa.gov.cn\/yaopin\/ypggtg\/ypqtgg\/20180125135801903.html."},{"issue":"5","key":"e_1_2_10_15_1","first-page":"742","article-title":"The Influence of Specific Activity on the Biodistribution of 18F\u2010rhPSMA\u20107.3: A Retrospective Analysis of Clinical PET Data","volume":"63","author":"Langbein T.","year":"2022","journal-title":"Journal of Nuclear Medicine"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1186\/s41181\u2010021\u201000149\u20106"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2018.09.018"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.2174\/1874471013666200929125102"},{"volume-title":"Pharmacopoeia of the People's Republic of China 2020 Edition","year":"2020","key":"e_1_2_10_19_1"},{"key":"e_1_2_10_20_1","unstructured":"\u201cICH Harmonised Guideline Validation of Analytical Procedures Q2(R2) \u201dhttps:\/\/database.ich.org\/sites\/default\/files\/ICH_Q2%28R2%29_Guideline_2023_1130.pdf."},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1186\/s41181\u2010019\u20100086\u2010z"}],"container-title":["Journal of Labelled Compounds and Radiopharmaceuticals"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jlcr.4140","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,16]],"date-time":"2025-10-16T18:41:16Z","timestamp":1760640076000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/jlcr.4140"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3]]},"references-count":20,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025,3]]}},"alternative-id":["10.1002\/jlcr.4140"],"URL":"https:\/\/doi.org\/10.1002\/jlcr.4140","archive":["Portico"],"relation":{},"ISSN":["0362-4803","1099-1344"],"issn-type":[{"type":"print","value":"0362-4803"},{"type":"electronic","value":"1099-1344"}],"subject":[],"published":{"date-parts":[[2025,3]]},"assertion":[{"value":"2024-11-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-02-25","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-18","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e4140"}}