{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T18:56:38Z","timestamp":1783536998191,"version":"3.55.0"},"reference-count":63,"publisher":"Royal Society of Chemistry (RSC)","issue":"24","license":[{"start":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T00:00:00Z","timestamp":1787270400000},"content-version":"am","delay-in-days":597,"URL":"http:\/\/rsc.li\/journals-terms-of-use"}],"content-domain":{"domain":["rsc.org"],"crossmark-restriction":true},"short-container-title":["Analyst"],"abstract":"<jats:p>A risk assessment-driven Analytical Quality by Design (AQbD) approach was applied to develop and validate a headspace GC-MS\/MS method for simultaneous quantification of residual solvent impurities (RSIs) in pharmaceutical drug substances.<\/jats:p>","DOI":"10.1039\/d5an00653h","type":"journal-article","created":{"date-parts":[[2025,8,21]],"date-time":"2025-08-21T02:40:54Z","timestamp":1755744054000},"page":"5481-5500","update-policy":"https:\/\/doi.org\/10.1039\/rsc_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["AQbD-based headspace GC-MS\/MS method development under ICH Q14 guidelines for simultaneous analysis of residual solvents in pharmaceuticals"],"prefix":"10.1039","volume":"150","author":[{"given":"Bontha","family":"Koteswaramma","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER) 844102, Hajipur, Bihar, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shubham","family":"Dhiman","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER) 844102, Hajipur, Bihar, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kalva","family":"Bhadrayya","sequence":"additional","affiliation":[{"name":"Swaroop Tech Services Private Ltd, Hyderabad, 500062, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0404-3513","authenticated-orcid":false,"given":"Anupam","family":"Jana","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER) 844102, Hajipur, Bihar, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-7635-3886","authenticated-orcid":false,"given":"Ramalingam","family":"Peraman","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER) 844102, Hajipur, Bihar, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"292","published-online":{"date-parts":[[2025]]},"reference":[{"key":"D5AN00653H\/cit1\/1","first-page":"410","volume":"22","author":"Puranik","year":"2009","journal-title":"Pak. J. Pharm. Sci."},{"key":"D5AN00653H\/cit2\/1","doi-asserted-by":"crossref","first-page":"215","DOI":"10.1016\/S0939-6411(96)00037-9","volume":"43","author":"Witschi","year":"1997","journal-title":"Eur. J. Pharm. Biopharm."},{"key":"D5AN00653H\/cit3\/1","doi-asserted-by":"crossref","first-page":"107216","DOI":"10.1016\/j.porgcoat.2022.107216","volume":"173","author":"Thapliyal","year":"2022","journal-title":"Prog. Org. Coat."},{"key":"D5AN00653H\/cit4\/1","doi-asserted-by":"crossref","first-page":"298","DOI":"10.1016\/j.yrtph.2012.03.016","volume":"63","author":"Snodin","year":"2012","journal-title":"Regul. Toxicol. Pharmacol."},{"key":"D5AN00653H\/cit5\/1","doi-asserted-by":"crossref","first-page":"273","DOI":"10.3109\/10408444.2015.1016216","volume":"45","author":"Mckee","year":"2015","journal-title":"Crit. Rev. Toxicol."},{"key":"D5AN00653H\/cit6\/1","doi-asserted-by":"crossref","first-page":"282","DOI":"10.1016\/j.yrtph.2006.01.004","volume":"44","author":"Dobo","year":"2006","journal-title":"Regul. Toxicol. Pharmacol."},{"key":"D5AN00653H\/cit7\/1","doi-asserted-by":"crossref","first-page":"199","DOI":"10.1002\/9781118971147.ch7","volume-title":"ICH quality guidelines: an implementation guide","author":"Connelly","year":"2017","unstructured":"J.Connelly ,  ICH quality guidelines: an implementation guide ,  2017 , pp.  199\u2013232"},{"key":"D5AN00653H\/cit8\/1","doi-asserted-by":"crossref","first-page":"167","DOI":"10.1002\/9781118971147.ch6","volume-title":"ICH Quality Guidelines: An Implementation Guide","author":"Teasdale","year":"2017","unstructured":"A.Teasdale ,  D.Elder ,  J.Harvey  and  S.Spanhaak ,  ICH Quality Guidelines: An Implementation Guide ,  2017 , pp.  167\u2013198"},{"key":"D5AN00653H\/cit9\/1","first-page":"60","volume":"25","author":"Countryman","year":"2007","journal-title":"LCGC North Am."},{"key":"D5AN00653H\/cit10\/1","doi-asserted-by":"crossref","first-page":"607","DOI":"10.1016\/B978-0-08-102824-7.00023-3","volume-title":"Specification of Drug Substances and Products","author":"Sheinin","year":"2020","unstructured":"E. B.Sheinin ,  Specification of Drug Substances and Products ,  Elsevier ,  2020 , pp.  607\u2013637"},{"key":"D5AN00653H\/cit11\/1","first-page":"2691","volume-title":"Encyclopedia of Pharmaceutical Science and Technology","author":"Keitel","year":"2013","unstructured":"S.Keitel ,  Encyclopedia of Pharmaceutical Science and Technology ,  2013 , pp.  2691\u20132703"},{"key":"D5AN00653H\/cit12\/1","first-page":"529","volume":"24","author":"Puranik","year":"2008","journal-title":"Orient. J. Chem."},{"key":"D5AN00653H\/cit13\/1","doi-asserted-by":"crossref","first-page":"119713","DOI":"10.1016\/j.ijpharm.2020.119713","volume":"588","author":"Mazumder","year":"2020","journal-title":"Int. J. Pharm."},{"key":"D5AN00653H\/cit14\/1","doi-asserted-by":"crossref","first-page":"149","DOI":"10.1007\/s11095-020-02877-x","volume":"37","author":"Dikpati","year":"2020","journal-title":"Pharm. Res."},{"key":"D5AN00653H\/cit15\/1","doi-asserted-by":"crossref","first-page":"135","DOI":"10.1016\/j.ijpharm.2013.07.077","volume":"456","author":"Ali","year":"2013","journal-title":"Int. J. Pharm."},{"key":"D5AN00653H\/cit16\/1","doi-asserted-by":"crossref","first-page":"3445","DOI":"10.3390\/ma15103445","volume":"15","author":"Othman","year":"2022","journal-title":"Materials"},{"key":"D5AN00653H\/cit17\/1","doi-asserted-by":"crossref","first-page":"493","DOI":"10.1007\/BF02977682","volume":"28","author":"Cao","year":"2005","journal-title":"Arch. Pharmacal Res."},{"key":"D5AN00653H\/cit18\/1","doi-asserted-by":"crossref","first-page":"4286","DOI":"10.1021\/la0629680","volume":"23","author":"Lua","year":"2007","journal-title":"Langmuir"},{"key":"D5AN00653H\/cit19\/1","doi-asserted-by":"crossref","first-page":"242","DOI":"10.1016\/j.nano.2010.07.003","volume":"7","author":"Das","year":"2011","journal-title":"Nanomedicine"},{"key":"D5AN00653H\/cit20\/1","doi-asserted-by":"crossref","first-page":"278","DOI":"10.1016\/j.ijpharm.2009.12.024","volume":"387","author":"Mayo","year":"2010","journal-title":"Int. J. Pharm."},{"key":"D5AN00653H\/cit21\/1","doi-asserted-by":"crossref","first-page":"126","DOI":"10.1016\/j.ijpharm.2007.03.011","volume":"340","author":"Kassem","year":"2007","journal-title":"Int. J. Pharm."},{"key":"D5AN00653H\/cit22\/1","doi-asserted-by":"crossref","first-page":"115","DOI":"10.3109\/02652048.2011.630108","volume":"29","author":"Van de Ven","year":"2012","journal-title":"J. Microencapsulation"},{"key":"D5AN00653H\/cit23\/1","doi-asserted-by":"crossref","first-page":"10098","DOI":"10.1021\/la500452h","volume":"30","author":"Choi","year":"2014","journal-title":"Langmuir"},{"key":"D5AN00653H\/cit24\/1","doi-asserted-by":"crossref","first-page":"1301","DOI":"10.1248\/cpb.c19-00621","volume":"67","author":"Kameyama","year":"2019","journal-title":"Chem. Pharm. Bull."},{"key":"D5AN00653H\/cit25\/1","doi-asserted-by":"crossref","first-page":"473","DOI":"10.1093\/chromsci\/bmy026","volume":"56","author":"Shah","year":"2018","journal-title":"J. Chromatogr. Sci."},{"key":"D5AN00653H\/cit26\/1","doi-asserted-by":"crossref","first-page":"408","DOI":"10.1016\/j.jpba.2016.06.020","volume":"128","author":"Tian","year":"2016","journal-title":"J. Pharm. Biomed. Anal."},{"key":"D5AN00653H\/cit27\/1","doi-asserted-by":"crossref","first-page":"197","DOI":"10.1016\/S0731-7085(00)00270-3","volume":"23","author":"Camarasu","year":"2000","journal-title":"J. Pharm. Biomed. Anal."},{"key":"D5AN00653H\/cit28\/1","doi-asserted-by":"crossref","first-page":"623","DOI":"10.1016\/S0731-7085(98)00276-3","volume":"18","author":"Camarasu","year":"1998","journal-title":"J. Pharm. Biomed. Anal."},{"key":"D5AN00653H\/cit29\/1","doi-asserted-by":"crossref","first-page":"162","DOI":"10.1016\/j.jpba.2012.10.019","volume":"74","author":"Armstrong","year":"2013","journal-title":"J. Pharm. Biomed. Anal."},{"key":"D5AN00653H\/cit30\/1","doi-asserted-by":"crossref","first-page":"487","DOI":"10.1093\/chromsci\/bmv175","volume":"54","author":"Feng","year":"2016","journal-title":"J. Chromatogr. Sci."},{"key":"D5AN00653H\/cit31\/1","doi-asserted-by":"crossref","first-page":"e3788","DOI":"10.1002\/bmc.3788","volume":"31","author":"Farajzadeh","year":"2017","journal-title":"Biomed. Chromatogr."},{"key":"D5AN00653H\/cit32\/1","doi-asserted-by":"crossref","first-page":"17150","DOI":"10.1039\/C5RA00125K","volume":"5","author":"Gad","year":"2015","journal-title":"RSC Adv."},{"key":"D5AN00653H\/cit33\/1","doi-asserted-by":"crossref","first-page":"340176","DOI":"10.1016\/j.aca.2022.340176","volume":"1221","author":"Hanafi","year":"2022","journal-title":"Anal. Chim. Acta"},{"key":"D5AN00653H\/cit34\/1","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1208\/s12248-022-00685-2","volume":"24","author":"Verch","year":"2022","journal-title":"AAPS J."},{"key":"D5AN00653H\/cit35\/1","doi-asserted-by":"crossref","first-page":"6088","DOI":"10.1016\/j.chroma.2009.06.067","volume":"1216","author":"Jalali-Heravi","year":"2009","journal-title":"J. Chromatogr., A"},{"key":"D5AN00653H\/cit36\/1","doi-asserted-by":"crossref","first-page":"2200117","DOI":"10.1002\/sscp.202200117","volume":"6","author":"Dhiman","year":"2023","journal-title":"Sep. Sci. plus"},{"key":"D5AN00653H\/cit37\/1","doi-asserted-by":"crossref","first-page":"329","DOI":"10.1080\/22297928.2014.999121","volume":"4","author":"Peraman","year":"2014","journal-title":"Anal. Chem. Lett."},{"key":"D5AN00653H\/cit38\/1","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1016\/B978-0-12-815799-2.00005-8","volume-title":"Pharmaceutical Quality by Design","author":"Ramalingam","year":"2019","unstructured":"P.Ramalingam  and  B.Jahnavi ,  Pharmaceutical Quality by Design ,  Elsevier ,  2019 , pp.  77\u2013108"},{"key":"D5AN00653H\/cit39\/1","doi-asserted-by":"crossref","first-page":"2300605","DOI":"10.1002\/jssc.202300605","volume":"47","author":"Pawar","year":"2024","journal-title":"J. Sep. Sci."},{"key":"D5AN00653H\/cit40\/1","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/s42452-019-0233-x","volume":"1","author":"Sojitra","year":"2019","journal-title":"SN Appl. Sci."},{"key":"D5AN00653H\/cit41\/1","doi-asserted-by":"crossref","first-page":"197","DOI":"10.1080\/10826076.2021.1874982","volume":"44","author":"Peraman","year":"2021","journal-title":"J. Liq. Chromatogr. Relat. Technol."},{"key":"D5AN00653H\/cit42\/1","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/s00769-024-01587-w","volume":"30","author":"Sathuluri","year":"2025","journal-title":"Accredit. Qual. Assur."},{"key":"D5AN00653H\/cit43\/1","doi-asserted-by":"crossref","first-page":"2577","DOI":"10.1021\/acs.analchem.8b04596","volume":"91","author":"Jackson","year":"2019","journal-title":"Anal. Chem."},{"key":"D5AN00653H\/cit44\/1","doi-asserted-by":"crossref","first-page":"1784","DOI":"10.1021\/acs.oprd.9b00238","volume":"23","author":"Tome","year":"2019","journal-title":"Org. Process Res. Dev."},{"key":"D5AN00653H\/cit45\/1","doi-asserted-by":"crossref","first-page":"1033","DOI":"10.1007\/s00216-023-05093-9","volume":"416","author":"Schwalb","year":"2024","journal-title":"Anal. Bioanal. Chem."},{"key":"D5AN00653H\/cit46\/1","doi-asserted-by":"crossref","first-page":"859","DOI":"10.1093\/chromsci\/bmab130","volume":"60","author":"Prajapati","year":"2022","journal-title":"J. Chromatogr. Sci."},{"key":"D5AN00653H\/cit47\/1","doi-asserted-by":"crossref","first-page":"160","DOI":"10.1093\/chromsci\/bmac030","volume":"61","author":"Prajapati","year":"2023","journal-title":"J. Chromatogr. Sci."},{"key":"D5AN00653H\/cit48\/1","doi-asserted-by":"crossref","first-page":"188","DOI":"10.2174\/0115734129285465240408044841","volume":"20","author":"Chaturvedi","year":"2024","journal-title":"Curr. Pharm. Anal."},{"key":"D5AN00653H\/cit49\/1","doi-asserted-by":"crossref","first-page":"201","DOI":"10.1093\/chromsci\/bmac068","volume":"62","author":"Prajapati","year":"2024","journal-title":"J. Chromatogr. Sci."},{"key":"D5AN00653H\/cit50\/1","first-page":"233","volume":"45","author":"Aksu","year":"2015","journal-title":"J. Fac. Pharm. Istanbul Univ."},{"key":"D5AN00653H\/cit51\/1","doi-asserted-by":"crossref","first-page":"986","DOI":"10.1093\/jaoacint\/qsac025","volume":"105","author":"Prajapati","year":"2022","journal-title":"J. AOAC Int."},{"key":"D5AN00653H\/cit52\/1","first-page":"1","author":"Sathuluri","year":"2024","journal-title":"Accredit. Qual. Assur."},{"key":"D5AN00653H\/cit53\/1","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1007\/s42452-019-0233-x","volume":"1","author":"Sojitra","year":"2019","journal-title":"SN Appl. Sci."},{"key":"D5AN00653H\/cit54\/1","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1186\/s43094-022-00401-z","volume":"8","author":"Gudibanda","year":"2022","journal-title":"Future J. Pharm. Sci."},{"key":"D5AN00653H\/cit55\/1","doi-asserted-by":"crossref","first-page":"40","DOI":"10.1186\/s43094-021-00186-7","volume":"7","author":"Noorbasha","year":"2021","journal-title":"Future J. Pharm. Sci."},{"issue":"9","key":"D5AN00653H\/cit56\/1","doi-asserted-by":"crossref","first-page":"845","DOI":"10.1016\/j.dental.2005.11.012","volume":"22","author":"Viljanen","year":"2006","journal-title":"Dent. Mater."},{"key":"D5AN00653H\/cit57\/1","doi-asserted-by":"crossref","first-page":"113796","DOI":"10.1016\/j.jpba.2020.113796","volume":"194","author":"Kay","year":"2021","journal-title":"J. Pharm. Biomed. Anal."},{"key":"D5AN00653H\/cit58\/1","doi-asserted-by":"crossref","first-page":"935","DOI":"10.1016\/j.nucmedbio.2006.07.003","volume":"33","author":"Klok","year":"2006","journal-title":"Nucl. Med. Biol."},{"key":"D5AN00653H\/cit59\/1","doi-asserted-by":"crossref","first-page":"882","DOI":"10.1093\/chromsci\/bmx052","volume":"55","author":"Bao","year":"2017","journal-title":"J. Chromatogr. Sci."},{"issue":"12","key":"D5AN00653H\/cit60\/1","doi-asserted-by":"crossref","first-page":"1894","DOI":"10.1248\/cpb.48.1894","volume":"48","author":"Urakami","year":"2000","journal-title":"Chem. Pharm. Bull."},{"key":"D5AN00653H\/cit61\/1","first-page":"2349","author":"Dubey","year":"2020","journal-title":"Indian Res. J. Pharm. Sci."},{"key":"D5AN00653H\/cit62\/1","doi-asserted-by":"crossref","first-page":"262","DOI":"10.1016\/j.jpba.2018.06.002","volume":"158","author":"Wang","year":"2018","journal-title":"J. Pharm. Biomed. Anal."},{"key":"D5AN00653H\/cit63\/1","doi-asserted-by":"crossref","first-page":"147","DOI":"10.52711\/2231-5691.2021.00028","volume":"11","author":"Telavane","year":"2021","journal-title":"Asian J. Pharm. Res."}],"container-title":["The Analyst"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/pubs.rsc.org\/en\/content\/articlepdf\/2025\/AN\/D5AN00653H","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,8]],"date-time":"2026-07-08T17:38:51Z","timestamp":1783532331000},"score":1,"resource":{"primary":{"URL":"https:\/\/pubs.rsc.org\/an\/article\/150\/24\/5481-5500\/880014"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025]]},"references-count":63,"journal-issue":{"issue":"24","published-print":{"date-parts":[[2025,12,1]]}},"URL":"https:\/\/doi.org\/10.1039\/d5an00653h","relation":{},"ISSN":["0003-2654","1364-5528"],"issn-type":[{"value":"0003-2654","type":"print"},{"value":"1364-5528","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025]]}}}