{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T17:08:51Z","timestamp":1780506531410,"version":"3.54.1"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T00:00:00Z","timestamp":1777507200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,4,30]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>In recent years, the government of India has banned single-use plastic, as it is more customer-friendly but poses major disadvantages, such as leaching. As impurities can be present in any source, from the raw material to the end product, and so on, these are scientifically termed extractables and leachables. To identify these types of impurities from the pharmaceutical formulation, predominantly parenteral and ophthalmic or any other products available in plastic packaging, a rapid, selective, and simultaneous method for four different analytes has been developed with the help of gas chromatography\u2013mass spectrometry and validated completely according to International Council for Harmonization Q2(R1) guidelines. Selected extractables and leachables, namely cyclohexanone, 2,4,7,9-tetramethyl-5-decyne-4,7-diol, bis(2-ethylhexyl) sulfosuccinate sodium salt, and benzophenone, were detected by mass spectrometry and identified using the NIST17 library of the instrument. The developed method was within the range.<\/jats:p>","DOI":"10.1093\/chromsci\/bmag019","type":"journal-article","created":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T11:35:14Z","timestamp":1779190514000},"source":"Crossref","is-referenced-by-count":0,"title":["Development and validation of gas chromatography\u2013mass spectrometry method for identification and quantification of selected non-intentionally added substances IN pharmaceutical formulations"],"prefix":"10.1093","volume":"64","author":[{"given":"Stuti","family":"Pandya","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Sciences, Saurashtra University , University road, Rajkot-360005, Gujarat ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nasir","family":"Vadia","sequence":"additional","affiliation":[{"name":"Faculty of Pharmacy, Marwadi University , Rajkot-Morbi road, Rajkot-360003, Gujarat ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-4186-3910","authenticated-orcid":false,"given":"Navin","family":"Sheth","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Sciences, Saurashtra University , University road, Rajkot-360005, Gujarat ,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,6,3]]},"reference":[{"key":"2026060312294192100_ref1","volume-title":"Indian Pharmacopoeia. 9th ed. 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Recommendations for Extractables and Leachables testing, part 1: Introduction, regulatory issues, and risk assessment","volume":"6","author":"Colton","year":"2008","journal-title":"Bioprocess International"},{"key":"2026060312294192100_ref18","doi-asserted-by":"publisher","DOI":"10.5731\/pdajpst.2015.01073","article-title":"Creating a holistic extractables and leachables (E&L) program for biotechnology products","volume":"69","author":"","journal-title":"PDA journal of pharmaceutical science and technology"},{"key":"2026060312294192100_ref3","doi-asserted-by":"publisher","first-page":"448","DOI":"10.5731\/pdajpst.2013.00933","article-title":"Extractables characterization for five materials of construction representative of packaging systems used for parenteral and ophthalmic drug products","volume":"67","author":"Jenke","year":"2013","journal-title":"PDA Journal of Pharmaceutical Science and Technology"},{"key":"2026060312294192100_ref23","doi-asserted-by":"publisher","first-page":"1768","DOI":"10.1080\/10826070902959497","article-title":"HPLC and LC\/MS analysis of pharmaceutical container closure system leachables and extractables","volume":"32","author":"Norwood","year":"2009","journal-title":"Journal of Liquid Chromatography & Related Technologies\u00ae"},{"key":"2026060312294192100_ref4","volume-title":"Safety thresholds and best practices for extractables and leachables in orally inhaled and nasal drug products","author":"Product Quality Research Institute (PQRI)","year":"2006"},{"key":"2026060312294192100_ref5","volume-title":"Technical report No. 66: Application of Extractables and Leachables for pharmaceutical packaging systems","author":"Parenteral Drug Association (PDA)","year":"2015"},{"key":"2026060312294192100_ref20","doi-asserted-by":"publisher","first-page":"12","DOI":"10.5731\/pdajpst.2012.00803","article-title":"Interactions between therapeutic proteins and acrylic acid leachable","volume":"66","author":"Liu","year":"2012","journal-title":"PDA Journal of Pharmaceutical Science and Technology"},{"key":"2026060312294192100_ref6","volume-title":"Container closure Systems for Packaging Human Drugs and Biologics","author":"US Food and Drug Administration","year":"1999"},{"issue":"9","key":"2026060312294192100_ref37","doi-asserted-by":"publisher","first-page":"2115","DOI":"10.3390\/molecules25092115","article-title":"Identification of potential extractables and leachables in cosmetic plastic packaging by microchambers-thermal extraction and pyrolysis-gas chromatography-mass spectrometry","volume":"25","author":"Murat","year":"2020","journal-title":"Molecules"},{"key":"2026060312294192100_ref7","volume-title":"Guideline on plastic immediate packaging materials","author":"European Medicines Agency","year":"2005"},{"key":"2026060312294192100_ref8","volume-title":"Drugs and Cosmetics Act, 1940 and Rules, 1945","author":"Central Drugs Standard Control Organization (CDSCO)"},{"key":"2026060312294192100_ref17","doi-asserted-by":"publisher","first-page":"407","DOI":"10.5731\/pdajpst.2014.00995","article-title":"A compilation of safety impact information for extractables associated with materials used in pharmaceutical packaging, delivery, administration, and manufacturing systems","volume":"68","author":"Jenke","year":"2014","journal-title":"PDA journal of pharmaceutical science and technology."},{"key":"2026060312294192100_ref9","volume-title":"International Council for Harmonisation of technical requirements for Pharmaceuticals for Human use. ICH Q3E: Guideline on Extractables and Leachables","year":"2023"},{"key":"2026060312294192100_ref22","doi-asserted-by":"publisher","first-page":"1410","DOI":"10.1016\/j.eurpolymj.2004.10.016","article-title":"Nonisothermal crystallisation, melting behavior and wide-angle X-ray scattering investigations on linear low-density polyethylene (LLDPE)\/ethylene vinyl acetate (EVA) blends: Effects of compatibilisation and dynamic crosslinking","volume":"41","author":"Moly","year":"2005","journal-title":"European Polymer Journal."},{"key":"2026060312294192100_ref10","doi-asserted-by":"publisher","first-page":"3499","DOI":"10.1002\/app.32713","article-title":"Evaluation of the effects of biobased plasticiser on the thermal, mechanical, dynamic mechanical properties, and permanence of plasticised PVC","volume":"118","author":"Benaniba","year":"2010","journal-title":"Journal of Applied Polymer Science"},{"key":"2026060312294192100_ref31","doi-asserted-by":"publisher","first-page":"119332","DOI":"10.1016\/j.ijpharm.2020.119332","article-title":"Leachables from plastic materials in contact with drugs. State of the art and review of current analytical approaches","volume":"583","author":"Cuadros-Rodr\u00edguez","year":"2020","journal-title":"International Journal of Pharmaceutics"},{"key":"2026060312294192100_ref33","author":"Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics, U.S Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research","year":"1999"},{"key":"2026060312294192100_ref11","volume-title":"Recommendations for extractables and leachables testing, part 2: Executing a program","author":"Extractables and Leachables Subcommittee of the Bio-Process Systems Alliance","year":"2008"},{"key":"2026060312294192100_ref24","doi-asserted-by":"publisher","first-page":"430","DOI":"10.5731\/pdajpst.2013.00936","article-title":"The product quality research institute (PQRI) leachables and extractables working group initiatives for parenteral and ophthalmic drug product (PODP)","volume":"67","author":"Paskiet","year":"2013","journal-title":"PDA Journal of Pharmaceutical Science and Technology"},{"key":"2026060312294192100_ref30","doi-asserted-by":"publisher","first-page":"201","DOI":"10.1016\/j.yrtph.2016.08.011","article-title":"Assessing safety of extractables from materials and leachables in pharmaceuticals and biologics \u2013 Current challenges and approaches","volume":"81","author":"Broschard","year":"2016","journal-title":"Regulatory Toxicology and Pharmacology"},{"key":"2026060312294192100_ref25","volume-title":"British pharmacopoeia","author":"Pharmacopoeia","year":"2013"},{"key":"2026060312294192100_ref19","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.ejpb.2015.12.005","article-title":"Matrix effect on leaching of Bisphenol a diglycidyl ether (BADGE) from epoxy resin based inner lacquer of aluminium tubes into semi-solid dosage forms","volume":"101","author":"Lipke","year":"2016","journal-title":"European Journal of Pharmaceutics and Biopharmaceutics."},{"key":"2026060312294192100_ref35","volume-title":"Development of GC-MS methods for the identification and quantification of leachables from plastic packaging in dialysis solutions (Doctoral dissertation)","author":"Athenst\u00e4dt","year":"2013"},{"key":"2026060312294192100_ref12","doi-asserted-by":"publisher","DOI":"10.4172\/2155-9872.1000222","article-title":"GC-MS technique and its analytical applications in science and technology","volume":"5","author":"Chauhan","year":"2014","journal-title":"J Anal Bioanal Tech"},{"key":"2026060312294192100_ref27","doi-asserted-by":"publisher","first-page":"882","DOI":"10.1039\/an9770200882","article-title":"Communication. 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