{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,25]],"date-time":"2026-01-25T04:04:01Z","timestamp":1769313841914,"version":"3.49.0"},"reference-count":16,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2021,5,5]],"date-time":"2021-05-05T00:00:00Z","timestamp":1620172800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,2,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>This work describes the highly selective and sensitive robust analytical method (gas chromatography) for the qualitative and quantitative analysis of commonly used residual solvents (like methanol, ethanol, acetonitrile, dichloromethane, methyl tert-butyl ether, n-hexane, 1-propanol, ethyl acetate, tetrahydrofuran, N,N-diisopropylethylamine (DIPEA) and dimethylformamide), in an active pharmaceuticals ingredients. The developed method was optimized with good resolution (&amp;gt;1.9 between close eluting solvents) and a shorter run time (20\u00a0min). All the solvents were separated using GC column DB\u2013624, 30-m length, 0.32-mm diameter, 1.8-\u03bcm particle size, nitrogen as a carrier gas and recorded the signals using flame ionization detector (FID). Further, analytical method validation has been performed for the developed analytical method and the validation results demonstrated its routine application for the determination of residual solvents content by GC\u2013head space (HS). The practical application was demonstrated by the suitable API batch analysis (having sample Con. 40\u00a0mg\/mL). The present developed method has more advantages than the other methods for the qualitative and quantitative applications, such as shorter runtime, selective for multiple solvents (11 organic solvents) analysis at a time, highly sensitive at ppm levels. This GC\u2013HS method could be used for the qualitative and quantitative determination of the residual solvents content in APIs.<\/jats:p>","DOI":"10.1093\/chromsci\/bmab051","type":"journal-article","created":{"date-parts":[[2021,4,20]],"date-time":"2021-04-20T11:48:53Z","timestamp":1618919333000},"page":"117-125","source":"Crossref","is-referenced-by-count":4,"title":["Shorter and Rugged Analytical GC Method for Residual Solvents Content in Active Pharmaceutical Ingredient"],"prefix":"10.1093","volume":"60","author":[{"given":"S","family":"Ramanjaneyulu","sequence":"first","affiliation":[{"name":"Determent of Analytical R&D, Inogent Laboratories Ltd. (A GVK Bio Company), Plot No 28, A, IDA, Industrial Development Area, Nacharam, Hyderabad 500076, India"},{"name":"Department of Physical and Nuclear Chemistry and Chemical Oceanography, Andhra University, Waltair Junction, Visakhapatnam 530 003, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K M V Narayana","family":"Rao","sequence":"additional","affiliation":[{"name":"Determent of Analytical R&D, Inogent Laboratories Ltd. (A GVK Bio Company), Plot No 28, A, IDA, Industrial Development Area, Nacharam, Hyderabad 500076, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shyamala","family":"Pulipaka","sequence":"additional","affiliation":[{"name":"Department of Physical and Nuclear Chemistry and Chemical Oceanography, Andhra University, Waltair Junction, Visakhapatnam 530 003, India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2021,5,5]]},"reference":[{"issue":"7574","key":"2022021704534922100_ref1","doi-asserted-by":"crossref","first-page":"873","DOI":"10.1136\/bmj.333.7574.873-a","article-title":"European Medicines Agency gives favourable ruling on NSAIDs","volume":"333","author":"Watson","year":"2006","journal-title":"BMJ: British Medical Journal"},{"key":"2022021704534922100_ref2","first-page":"33","article-title":"Assessment of genotoxic impurities in pharmaceuticals by in-silico and in-situ derivatization-headspace GC-MS methodology","volume":"5","author":"Waykar","year":"2013","journal-title":"Int. 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