{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T12:25:25Z","timestamp":1790425525825,"version":"4.1.0"},"reference-count":34,"publisher":"Wiley","issue":"23","license":[{"start":{"date-parts":[[2024,12,8]],"date-time":"2024-12-08T00:00:00Z","timestamp":1733616000000},"content-version":"vor","delay-in-days":7,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Separation Science"],"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>Advances in techniques for quality analysis allow for a more detailed examination of drug impurities. High\u2010resolution mass spectrometry (HRMS) contributes to detecting both known and unknown impurities. In this study, a combination of a nontargeted and targeted screening approach was established and applied to the detailed degradation profile of the losartan potassium (LP) drug substance. Through general unknown comparative screening (GUCS), 35 degradation products (DPs) were detected; of these, 10 DPs were confirmed with reference substances. DP\u20101, DP\u20102, DP\u20103, and DP\u20106 were the first characterized, as per previous studies; the other twenty\u2010four were newly identified. In addition, a liquid chromatography\u2010tandem mass spectrometry method was developed for the determination of the ten DPs. It was sensitive, with the limit of quantitation of analytes ranging from 0.01 to 0.5\u00a0ng mL<jats:sup>\u22121<\/jats:sup>. Two newly characterized DPs, DP\u20101 and DP\u20102, were determined in active pharmaceutical ingredient solutions. This study introduced a new approach using broad screening to analyze degradation impurity profiles in LP drug substance, aiding in the identification of low\u2010level impurities or those without reference substances. Additionally, the sensitive determination method developed allows for the precise quantification and control of ten DPs at trace levels in LP drug substances or products.<\/jats:p>","DOI":"10.1002\/jssc.70027","type":"journal-article","created":{"date-parts":[[2024,12,8]],"date-time":"2024-12-08T23:10:34Z","timestamp":1733699434000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Application of Advanced High\u2010Resolution Mass Spectrometric Techniques for the Analysis of Losartan Potassium Drug Substance Degradation Products: From Nontargeted to Targeted Screening"],"prefix":"10.1002","volume":"47","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-2077-3072","authenticated-orcid":false,"given":"Jiaxuan","family":"Xia","sequence":"first","affiliation":[{"name":"School of Pharmaceutical Sciences (Shenzhen) Shenzhen Campus of Sun Yat\u2010sen University  Shenzhen Guangdong China"},{"name":"NMPA Key Laboratory for Bioequivalence Research of Generic Drug Evaluation Shenzhen Institute for Drug Control  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yibao","family":"Jin","sequence":"additional","affiliation":[{"name":"NMPA Key Laboratory for Bioequivalence Research of Generic Drug Evaluation Shenzhen Institute for Drug Control  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanjun","family":"Hong","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences (Shenzhen) Shenzhen Campus of Sun Yat\u2010sen University  Shenzhen Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaolong","family":"Huang","sequence":"additional","affiliation":[{"name":"General Business Department Greater Bay Area Center for Drug Evaluation and Inspection of National Medical Products Administration  Shenzhen Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Pan","sequence":"additional","affiliation":[{"name":"General Business Department Greater Bay Area Center for Drug Evaluation and Inspection of National Medical Products Administration  Shenzhen Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kunhui","family":"Sun","sequence":"additional","affiliation":[{"name":"NMPA Key Laboratory for Bioequivalence Research of Generic Drug Evaluation Shenzhen Institute for Drug Control  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meifang","family":"Li","sequence":"additional","affiliation":[{"name":"NMPA Key Laboratory for Bioequivalence Research of Generic Drug Evaluation Shenzhen Institute for Drug Control  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiyong","family":"Xie","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences (Shenzhen) Shenzhen Campus of Sun Yat\u2010sen University  Shenzhen Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bing","family":"Wang","sequence":"additional","affiliation":[{"name":"NMPA Key Laboratory for Bioequivalence Research of Generic Drug Evaluation Shenzhen Institute for Drug Control  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,12,8]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/ajh\/5.12.209S"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003495\u2010199651050\u201000008"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpha.2013.09.003"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.5731\/pdajpst.2014.00974"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.xphs.2023.09.003"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.3390\/molecules26020301"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/10826076.2020.1731694"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.4103\/0250\u2010474X.106061"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.talanta.2009.06.060"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2006.04.030"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1365\/s10337\u2010009\u20101005\u20103"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.5937\/arhfarm1902080X"},{"key":"e_1_2_9_14_1","first-page":"3260","volume-title":"European Pharmacopoeia 11.0","author":"European Directorate for the Quality of Medicines & Healthcare","year":"2022"},{"key":"e_1_2_9_15_1","first-page":"1638","volume-title":"Chinese Pharmacopoeia 2020","author":"Chinese Medical Science and Technology Press","year":"2020"},{"key":"e_1_2_9_16_1","first-page":"1274","volume-title":"Japanese Pharmacopoeia 18","year":"2021"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.2174\/1573412910999141010152758"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0731\u20107085(97)00251\u20103"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2024.116160"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chroma.2023.464269"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.xphs.2022.12.005"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1093\/chromsci\/bmac059"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.talanta.2023.124481"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2015.11.037"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1002\/jssc.202400173"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.4489"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2023.115955"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.chroma.2017.10.043"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1021\/es5002105"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.molp.2023.09.010"},{"key":"e_1_2_9_31_1","first-page":"4295","article-title":"Isolation, Identification and Characterization of Process Related Impurities in Losartan Potassium Drug Substance","volume":"4","author":"Thapa M.","year":"2010","journal-title":"Asian Journal of Chemistry"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.1002\/rcm.9432"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0731\u20107085(99)00004\u20107"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088\u2010200544080\u201000003"},{"key":"e_1_2_9_35_1","first-page":"52","article-title":"Isolation and Purification of the Process Impurity in Losartan by Reversed\u2010Phase Column Chromatography","volume":"24","author":"Nie J.","year":"2006","journal-title":"Se Pu: Chinese Journal of Chromatography"}],"container-title":["Journal of Separation Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jssc.70027","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,19]],"date-time":"2025-10-19T14:34:06Z","timestamp":1760884446000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/jssc.70027"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,12]]},"references-count":34,"journal-issue":{"issue":"23","published-print":{"date-parts":[[2024,12]]}},"alternative-id":["10.1002\/jssc.70027"],"URL":"https:\/\/doi.org\/10.1002\/jssc.70027","archive":["Portico"],"relation":{},"ISSN":["1615-9306","1615-9314"],"issn-type":[{"value":"1615-9306","type":"print"},{"value":"1615-9314","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,12]]},"assertion":[{"value":"2024-12-08","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70027"}}