{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T03:52:18Z","timestamp":1793159538600,"version":"4.5.0"},"reference-count":31,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2024,8,23]],"date-time":"2024-08-23T00:00:00Z","timestamp":1724371200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004329","name":"Javna agencija za znanstvenoraziskovalno in inovacijsko dejavnost Republike Slovenije","doi-asserted-by":"publisher","award":["P1\\u20130189"],"award-info":[{"award-number":["P1\\u20130189"]}],"id":[{"id":"10.13039\/501100004329","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Talanta"],"published-print":{"date-parts":[[2025,1]]},"DOI":"10.1016\/j.talanta.2024.126752","type":"journal-article","created":{"date-parts":[[2024,9,7]],"date-time":"2024-09-07T07:48:10Z","timestamp":1725695290000},"page":"126752","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":24,"special_numbering":"C","title":["A comprehensive approach for N-nitrosamine determination in pharmaceuticals using a novel HILIC-based solid phase extraction and LC-HRMS"],"prefix":"10.1016","volume":"282","author":[{"given":"Timeja","family":"Planin\u0161ek Parfant","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Ro\u0161kar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.talanta.2024.126752_bib1","first-page":"1","article-title":"Lessons learnt from presence of N-nitrosamine impurities in sartan","year":"2020","journal-title":"medicines [Internet]"},{"issue":"10","key":"10.1016\/j.talanta.2024.126752_bib2","doi-asserted-by":"crossref","first-page":"1719","DOI":"10.1021\/acs.oprd.3c00100","article-title":"The nitrosamine \u201csaga\u201d: lessons learned from five years of scrutiny","volume":"27","author":"Nudelman","year":"2023","journal-title":"Org. Process Res. Dev."},{"issue":"5","key":"10.1016\/j.talanta.2024.126752_bib3","doi-asserted-by":"crossref","first-page":"1287","DOI":"10.1016\/j.xphs.2022.11.013","article-title":"The landscape of potential small and drug substance related nitrosamines in pharmaceuticals","volume":"112","author":"Schlingemann","year":"2023","journal-title":"J Pharm Sci"},{"issue":"3","key":"10.1016\/j.talanta.2024.126752_bib4","first-page":"1","article-title":"Questions and answers for marketing authorisation holders\/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726\/2004 referral on nitrosamine impurities in","volume":"5","year":"2024","journal-title":"human medicinal products"},{"key":"10.1016\/j.talanta.2024.126752_bib5","series-title":"Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) Guidance for Industry","year":"2023"},{"key":"10.1016\/j.talanta.2024.126752_bib6","doi-asserted-by":"crossref","first-page":"124102","DOI":"10.1016\/j.talanta.2022.124102","article-title":"Current status and prospects of development of analytical methods for determining nitrosamine and N -nitroso impurities in pharmaceuticals","volume":"254","author":"Wichitnithad","year":"2023","journal-title":"Talanta"},{"key":"10.1016\/j.talanta.2024.126752_bib7","series-title":"Commission adopts a new general chapter for the analysis of N-nitrosamine impurities","year":"2020"},{"key":"10.1016\/j.talanta.2024.126752_bib8","series-title":"USP-NF <1469> Nitrosamine Impurities","year":"2020"},{"issue":"June","key":"10.1016\/j.talanta.2024.126752_bib9","article-title":"Analysis of genotoxic N-nitrosamines in active pharmaceutical ingredients and market authorized products in low abundance by means of liquid chromatography \u2013 tandem mass spectrometry","volume":"219","author":"Vogel","year":"2022","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.talanta.2024.126752_bib10","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpba.2021.114561","article-title":"Isolation of N-nitrosodimethylamine from drug substances using solid-phase extraction-liquid chromatography\u2013tandem mass spectrometry","volume":"210","author":"Yamamoto","year":"2022","journal-title":"J. Pharm. Biomed. Anal."},{"issue":"February","key":"10.1016\/j.talanta.2024.126752_bib11","article-title":"Development of an analytical method for the determination and quantification of n-nitrosodimethylamine in olmesartan by HPLC-MS\/MS","volume":"179","author":"Gonz\u00e1lez","year":"2022","journal-title":"Microchem. J."},{"key":"10.1016\/j.talanta.2024.126752_bib12","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpba.2020.113460","article-title":"Determination of N-nitrosodimethylamine and N-nitrosomethylethylamine in drug substances and products of sartans, metformin and ranitidine by precipitation and solid phase extraction and gas chromatography\u2013tandem mass spectrometry","volume":"189","author":"Lim","year":"2020","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.talanta.2024.126752_bib13","volume":"vols. 1\u20136","year":"2020"},{"issue":"August","key":"10.1016\/j.talanta.2024.126752_bib14","article-title":"Evaluation and optimization of a HS-SPME-assisted GC-MS\/MS method for monitoring nitrosamine impurities in diverse pharmaceuticals","volume":"221","author":"Chang","year":"2022","journal-title":"J. Pharm. Biomed. Anal."},{"issue":"20","key":"10.1016\/j.talanta.2024.126752_bib15","doi-asserted-by":"crossref","DOI":"10.3390\/ijms232012125","article-title":"Development of a sensitive screening method for simultaneous determination of nine genotoxic nitrosamines in active pharmaceutical ingredients by GC-MS","volume":"23","author":"Witkowska","year":"2022","journal-title":"Int. J. Mol. Sci."},{"issue":"16","key":"10.1016\/j.talanta.2024.126752_bib16","doi-asserted-by":"crossref","first-page":"3067","DOI":"10.1002\/jssc.202200226","article-title":"Development and validation of rapid ultra high performance liquid chromatography with tandem mass spectroscopic method for the quantification of N-nitrosodimethyl amine and N-nitrosodiethyl amine in sitagliptin and metformin hydrochloride immediate and ex","volume":"45","author":"Mallavarapu","year":"2022","journal-title":"J Sep Sci"},{"key":"10.1016\/j.talanta.2024.126752_bib17","doi-asserted-by":"crossref","DOI":"10.1016\/j.chroma.2022.463605","article-title":"Development of dispersive inclusion complex microextraction for the analysis of nitrosamines in medicinal products","volume":"1685","author":"Tay","year":"2022","journal-title":"J. Chromatogr. A"},{"key":"10.1016\/j.talanta.2024.126752_bib18","doi-asserted-by":"crossref","DOI":"10.1016\/j.jpba.2021.113960","article-title":"Analytical lifecycle management for comprehensive and universal nitrosamine analysis in various pharmaceutical formulations by supercritical fluid chromatography","volume":"197","author":"Schmidtsdorff","year":"2021","journal-title":"J. Pharm. Biomed. Anal."},{"issue":"July 2023","key":"10.1016\/j.talanta.2024.126752_bib19","article-title":"A robust analytical method for simultaneous quantification of 13 low-molecular-weight N-Nitrosamines in various pharmaceuticals based on solid phase extraction and liquid chromatography coupled to high-resolution mass spectrometry","volume":"192","author":"Planin\u0161ek Parfant","year":"2024","journal-title":"Eur J Pharm Sci"},{"key":"10.1016\/j.talanta.2024.126752_bib20","doi-asserted-by":"crossref","DOI":"10.1155\/2019\/4848236","article-title":"Fast and simple LC-MS\/MS method for rifampicin quantification in human plasma","volume":"2019","author":"Temova Raku\u0161a","year":"2019","journal-title":"Int J Anal Chem"},{"issue":"12","key":"10.1016\/j.talanta.2024.126752_bib21","doi-asserted-by":"crossref","first-page":"6190","DOI":"10.1021\/acs.analchem.6b01167","article-title":"Understanding the complexity of porous graphitic carbon (PGC) chromatography: modulation of mobile-stationary phase interactions overcomes loss of retention and reduces variability","volume":"88","author":"Bapiro","year":"2016","journal-title":"Anal Chem."},{"key":"10.1016\/j.talanta.2024.126752_bib22","first-page":"1","article-title":"Liquid chromatography-electrospray ionization-high resolution mass spectrometry (LC-ESI-HRMS) method for the determination of nitrosamine impurities in metformin","year":"2020","journal-title":"Drug Substance and Drug Product"},{"key":"10.1016\/j.talanta.2024.126752_bib23","first-page":"47","article-title":"Method 521: determination of nitrosamines in drinking water by solid-phase extraction and capillary column gas chromatography with large volume injection and chemical ionization","year":"2004","journal-title":"tandem mass spectrometry (MS\/MS)"},{"key":"10.1016\/j.talanta.2024.126752_bib24","doi-asserted-by":"crossref","first-page":"109","DOI":"10.1016\/j.talanta.2015.01.019","article-title":"Determination of N-nitrosodiethanolamine, NDELA in cosmetic ingredients and products by mixed mode solid phase extraction and UPLC-tandem mass spectrometry with porous graphitic carbon column through systemic sample pre-cleanup procedure","volume":"137","author":"Joo","year":"2015","journal-title":"Talanta"},{"issue":"21","key":"10.1016\/j.talanta.2024.126752_bib25","doi-asserted-by":"crossref","DOI":"10.3390\/molecules25215204","article-title":"Sample preparation to determine pharmaceutical and personal care products in an all-water matrix: solid phase extraction","volume":"25","author":"Sadutto","year":"2020","journal-title":"Molecules"},{"issue":"4","key":"10.1016\/j.talanta.2024.126752_bib27","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1208\/s12248-020-00473-w","article-title":"A cautionary tale: quantitative LC-HRMS analytical procedures for the analysis of N-nitrosodimethylamine in metformin","volume":"22","author":"Yang","year":"2020","journal-title":"AAPS J."},{"issue":"12","key":"10.1016\/j.talanta.2024.126752_bib28","doi-asserted-by":"crossref","first-page":"2915","DOI":"10.1021\/acs.oprd.0c00462","article-title":"Ranitidine - investigations into the root cause for the presence of N-nitroso- N, N-dimethylamine in ranitidine hydrochloride drug substances and associated drug products","volume":"24","author":"King","year":"2020","journal-title":"Org. Process Res. Dev."},{"issue":"10","key":"10.1016\/j.talanta.2024.126752_bib29","doi-asserted-by":"crossref","first-page":"1008","DOI":"10.1248\/cpb.c20-00431","article-title":"Temperature-dependent formation of N-nitrosodimethylamine during the storage of ranitidine reagent powders and tablets","volume":"68","author":"Abe","year":"2020","journal-title":"Chem Pharm Bull"},{"key":"10.1016\/j.talanta.2024.126752_bib30","author":"Pharma"},{"key":"10.1016\/j.talanta.2024.126752_bib31","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1016\/j.chroma.2014.01.009","article-title":"Simultaneous determination of volatile and non-volatile nitrosamines in processed meat products by liquid chromatography tandem mass spectrometry using atmospheric pressure chemical ionisation and electrospray ionisation","volume":"1330","author":"Herrmann","year":"2014","journal-title":"J. Chromatogr. A"},{"key":"10.1016\/j.talanta.2024.126752_bib32","first-page":"1","article-title":"Lupin pharmaceuticals, Inc. Issues voluntarily nationwide recall of all irbesartan tablets and irbesartan and hydrochlorothiazide","year":"2021","journal-title":"Tablets Due to Potential Presence of N-nitrosoirbesartan Impurity"}],"container-title":["Talanta"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0039914024011317?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0039914024011317?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2024,11,17]],"date-time":"2024-11-17T12:30:51Z","timestamp":1731846651000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0039914024011317"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1]]},"references-count":31,"alternative-id":["S0039914024011317"],"URL":"https:\/\/doi.org\/10.1016\/j.talanta.2024.126752","relation":{},"ISSN":["0039-9140"],"issn-type":[{"value":"0039-9140","type":"print"}],"subject":[],"published":{"date-parts":[[2025,1]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"A comprehensive approach for N-nitrosamine determination in pharmaceuticals using a novel HILIC-based solid phase extraction and LC-HRMS","name":"articletitle","label":"Article Title"},{"value":"Talanta","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.talanta.2024.126752","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2024 The Authors. Published by Elsevier B.V.","name":"copyright","label":"Copyright"}],"article-number":"126752"}}