{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T00:31:26Z","timestamp":1760488286090,"version":"build-2065373602"},"reference-count":18,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2017,6,20]],"date-time":"2017-06-20T00:00:00Z","timestamp":1497916800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Drug Testing and Analysis"],"published-print":{"date-parts":[[2018,1]]},"abstract":"<jats:p>Seven unknown impurities in Repaglinide bulk drug batches at below 0.1% (ranging from 0.05 to 0.10%) were detected by an ultra\u2010performance liquid chromatographic (UPLC) method. These impurities were isolated from the crude sample of Repaglinide using preparative high performance liquid chromatography (prep\u2010HPLC). Based on liquid chromatography\u2010electrospray ionization\u2010mass spectrometry (LC\u2010ESI\/MS) study, the chemical structures of seven new impurities (<jats:bold>8<\/jats:bold>, <jats:bold>9<\/jats:bold>, <jats:bold>10<\/jats:bold>, <jats:bold>11<\/jats:bold>, <jats:bold>13<\/jats:bold>, <jats:bold>14,<\/jats:bold> and <jats:bold>16<\/jats:bold>) were presumed and characterized as 4\u2010(cyanomethyl)\u20102\u2010ethoxybenzoic acid (<jats:bold>8)<\/jats:bold>, 4\u2010(cyanomethyl)\u20102\u2010ethoxy\u2010<jats:italic>N<\/jats:italic>\u2010(3\u2010methyl\u20101\u2010(2\u2010(piperidin\u20101\u2010yl)phenyl)butyl)benzamide (<jats:bold>9<\/jats:bold>), 4\u2010(2\u2010amino\u20102\u2010oxoethyl)\u20102\u2010ethoxy\u2010<jats:italic>N<\/jats:italic>\u2010(3\u2010methyl\u20101\u2010(2\u2010(piperidin\u20101\u2010yl)phenyl)butyl) benzamide (<jats:bold>10<\/jats:bold>) and 2\u2010(3\u2010ethoxy\u20104\u2010((3\u2010methyl\u20101\u2010(2\u2010(piperidin\u20101\u2010yl)phenyl)butyl) carbamoyl) phenyl) acetic acid (<jats:bold>11)<\/jats:bold> and 4\u2010(cyanomethyl)\u2010<jats:italic>N<\/jats:italic>\u2010cyclohexyl\u20102\u2010ethoxybenzamide (<jats:bold>13)<\/jats:bold>, 2\u2010(4\u2010(cyclohexylcarbamoyl)\u20103\u2010ethoxyphenyl) acetic acid (<jats:bold>14)<\/jats:bold> and <jats:italic>N<\/jats:italic>\u2010cyclohexyl\u20104\u2010(2\u2010(cyclohexylamino)\u20102\u2010oxoethyl)\u20102\u2010ethoxybenzamide (<jats:bold>16)<\/jats:bold>. The complete spectral analysis, proton nuclear magnetic resonance (<jats:sup>1<\/jats:sup>H NMR), <jats:sup>13<\/jats:sup>C NMR, MS, and infrared (IR) confirmed the proposed chemical structures of impurities. Identification, structural characterization, formation, and their synthesis was first reported in this study. The impurity <jats:bold>11<\/jats:bold> was crystallized and structure was solved by single crystal X\u2010ray diffraction. Copyright \u00a9 2017 John Wiley &amp; Sons, Ltd.<\/jats:p>","DOI":"10.1002\/dta.2207","type":"journal-article","created":{"date-parts":[[2017,4,19]],"date-time":"2017-04-19T01:52:51Z","timestamp":1492566771000},"page":"212-221","source":"Crossref","is-referenced-by-count":3,"title":["Identification, isolation, and synthesis of seven novel impurities of anti\u2010diabetic drug Repaglinide"],"prefix":"10.1002","volume":"10","author":[{"given":"Prasad","family":"Kancherla","sequence":"first","affiliation":[{"name":"Institute of Science &amp;Technology JNT University  Kukatpally Hyderabad Telangana 500085 India"},{"name":"Green Evolution Laboratories  Nacharam Hyderabad Telangana 500017 India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Srinivas","family":"Keesari","sequence":"additional","affiliation":[{"name":"Green Evolution Laboratories  Nacharam Hyderabad Telangana 500017 India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pallavi","family":"Alegete","sequence":"additional","affiliation":[{"name":"Institute of Science &amp;Technology JNT University  Kukatpally Hyderabad Telangana 500085 India"},{"name":"Green Evolution Laboratories  Nacharam Hyderabad Telangana 500017 India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mukkanti","family":"Khagga","sequence":"additional","affiliation":[{"name":"Institute of Science &amp;Technology JNT University  Kukatpally Hyderabad Telangana 500085 India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9306-4956","authenticated-orcid":false,"given":"Parthasarathi","family":"Das","sequence":"additional","affiliation":[{"name":"Medicinal Chemistry Divison CSIR\u2010Indian Institute of Integrative Medicine  Canal Road Jammu 180001 India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,6,20]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.2165\/11207600-000000000-00000"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.2165\/00129784-200707050-00002"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2362.1999.00005.x"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.1.7.1455"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1021\/jm9810349"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2362.1999.00001.x"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0300-2977(99)00068-6"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1055\/s-0029-1212171"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/009127000004000107"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12249-013-0061-z"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.4103\/0110-5558.72422"},{"volume-title":"Q3A (R): Impurities in New Drug Substances","year":"2006","author":"International Conference on Harmonization (ICH)","key":"e_1_2_7_13_1"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/0731-7085(93)E0018-I"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1021\/ac961912f"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.2116\/analsci.19.1675"},{"key":"e_1_2_7_17_1","unstructured":"W.Grell R.Hurnaus G.Griss R.Sauter M.Reiffen E.Rupprecht.Phenylacetic acid benzylamides. 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