{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T12:09:58Z","timestamp":1785845398992,"version":"3.56.0"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2024,7,13]],"date-time":"2024-07-13T00:00:00Z","timestamp":1720828800000},"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":[[2024,11,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Class-I residual solvents such as 1,1-dichloroethene, 1,1,1-trichloroethane, carbon tetrachloride, benzene, 1,2-dichloroethane are toxic, environmental hazards, and carcinogenic to humans. A headspace-gas chromatography\u2013mass spectrometer is a sophisticated instrument for the quantification of residual solvents at lower limits.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>An exact, sensitive, reliable, and fast method was developed to determine 1,1-dichloroethene, 1,1,1-trichloroethane, carbon tetrachloride, benzene, and 1,2-dichloroethane present in different drug substances using a headspace-gas chromatography\u2013mass spectrometer.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Helium is used as a carrier gas. N-methyl-2-pyrrolidone is used as a diluent, and the stationary phase is a DB-624 (60\u2009m \u00d7 0.25\u2009mm \u00d7 1.4\u2009\u03bcm film thickness) column with a flow rate of 1.5\u2009mL\/min.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The concentration LODs for 1,1-dichloroethene, 1,1,1-trichloroethane, carbon tetrachloride, benzene, and 1,2-dichloroethane were 0.24, 5, 0.12, 0.06, and 0.15\u2009ppm. The concentrations LOQs for the aforementioned impurities were 0.8, 15, 0.4, 0.2, and 0.5\u2009ppm. The linearity was assessed over the range from LOQ to 120% of the specification level.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The current method's system suitability, precision, linearity, and accuracy parameters were assessed in accordance with the United states pharmacopeia (USP)\u2009&amp;lt;\u20091225&amp;gt; and International Conference on Harmonization of technical standards for the registration of medicines for human use (ICH) Q2(R2), and the results were within the acceptance criteria.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Highlights<\/jats:title>\n                  <jats:p>No research studies have been reported on determining class-I residual solvents in lincomycin hydrochloride, dapagliflozin, vonoprazan fumarate, and telmisartan drug substances. The proposed research aims to develop a common method for the quantification of class-I residual solvents for drug substances. The quality by design (QbD) concept is utilized in performance verification.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jaoacint\/qsae061","type":"journal-article","created":{"date-parts":[[2024,7,13]],"date-time":"2024-07-13T05:22:00Z","timestamp":1720848120000},"page":"921-933","source":"Crossref","is-referenced-by-count":14,"title":["Headspace Gas Chromatography\u2013Mass Spectrometry Method for Determination of Class-I Residual Solvents in Several Drug Substances: Method Evaluation by Quality by Design Statistical Tool"],"prefix":"10.1093","volume":"107","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7057-2608","authenticated-orcid":false,"given":"Kousrali","family":"Sayyad","sequence":"first","affiliation":[{"name":"Department of Chemistry, Koneru Lakshmaiah Education Foundation , Aziznagar, Hyderabad, Telangana 500075,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1199-2458","authenticated-orcid":false,"given":"Leela Prasad","family":"Kowtharapu","sequence":"additional","affiliation":[{"name":"Shenzhen DEC Pharmaceutical Co., Ltd, Analytical Development Department , Shenzhen 518000,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3060-795X","authenticated-orcid":false,"given":"Tanmoy","family":"Mondal","sequence":"additional","affiliation":[{"name":"Department of Chemistry, Koneru Lakshmaiah Education Foundation , Aziznagar, Hyderabad, Telangana 500075,","place":["India"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,7,13]]},"reference":[{"key":"2024110408521831900_qsae061-B1","author":"ICH Harmonised Guideline","year":"2024"},{"key":"2024110408521831900_qsae061-B2","author":"European Medicines Agency Evaluation of Medicines for Human Use Guideline","year":"2006"},{"key":"2024110408521831900_qsae061-B3","author":"ICH Harmonised Guideline","year":"2023"},{"key":"2024110408521831900_qsae061-B4","doi-asserted-by":"publisher","first-page":"113","DOI":"10.1080\/22297928.2019.1673814","volume":"10","author":"Konduru","year":"2020","journal-title":"Anal. 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