{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T05:14:53Z","timestamp":1778822093800,"version":"3.51.4"},"reference-count":18,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T00:00:00Z","timestamp":1778025600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T00:00:00Z","timestamp":1778025600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Biomedical Chromatography"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    A comprehensive, stability\u2010indicating, and environmentally sustainable analytical strategy was developed for the impurity and degradation profiling of iptacopan. Optimum separation was achieved on a Hypersil BDS C18 (250\u2009\u00d7\u20094.6\u2009mm, 5\u2009\u03bcm) column using 0.8\u2010mL\/min isocratic flow of 10\u2010mM ammonium acetate buffer (pH\u20094.5) and ethanol (60:40, v\/v) with 234\u2010nm UV detection. The method produced excellent linearity (\n                    <jats:italic>r<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    \u2009\u2265\u20090.9995), precision (%RSD\u2009\u2264\u20090.75), accuracy (98.32%\u2013100.26%), and robustness. Forced degradation studies generated four distinct degradation products (DPs) under acidic and oxidative stress, characterized by LC\u2013MS\/MS. DP 3 showed a +30\u2010Da mass increase (m\/z 453.4996), consistent with an indole\u2010carboxylic acid analogue, whereas DP 1 (m\/z 439.4730) exhibited a \u221214\u2010Da shift, indicating demethylation. DP 2 displayed a \u221242\u2010Da difference (m\/z 381.4369) due to dealkylation, and DP 4 showed a +14\u2010Da shift (m\/z 437.5002), corresponding to a linker ketone analogue. In silico toxicity assessment suggested moderate toxicity for most DPs, with DP 4 showing a comparatively favorable profile. Greenness and whiteness evaluation using AGREE (0.82), AGREE\u2010Prep (0.81), GAPI (E\u2010factor\u2009=\u200910), and RGB\u201012 (78.0%) confirmed excellent environmental and practical performance. The method provides a robust and sustainable platform for quality control and stability assessment of iptacopan.\n                  <\/jats:p>","DOI":"10.1002\/bmc.70483","type":"journal-article","created":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T10:12:57Z","timestamp":1778062377000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comprehensive Impurity and Degradation Profiling of Iptacopan Using a White\u2013Green Stability\u2010Indicating HPLC Method Coupled With LC\u2013MS\/MS and In Silico Toxicity Evaluation"],"prefix":"10.1002","volume":"40","author":[{"given":"Satyanarayana Reddy","family":"Jaggavarapu","sequence":"first","affiliation":[{"name":"Department of Chemistry Koneru Lakshmaiah Education Foundation  Guntur Andhra Pradesh India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4751-8379","authenticated-orcid":false,"given":"Ajmal R.","family":"Bhat","sequence":"additional","affiliation":[{"name":"Department of Chemistry RTM Nagpur University  Nagpur Maharashtra India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1705-2822","authenticated-orcid":false,"given":"Venkateswara Rao","family":"Anna","sequence":"additional","affiliation":[{"name":"Department of Chemistry Koneru Lakshmaiah Education Foundation  Guntur Andhra Pradesh India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,5,6]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.123.001290"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.18311\/ti\/2025\/v32i4\/48003"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/sscp.202400106"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2024.2404110"},{"key":"e_1_2_6_6_1","unstructured":"ICH Q1(R2).2003. \u201cStability Testing of New Drug Substances and Products.\u201d"},{"key":"e_1_2_6_7_1","unstructured":"ICH Q14.2023. \u201cAnalytical Procedure Development.\u201d"},{"key":"e_1_2_6_8_1","unstructured":"ICH Q2(R2).2022. \u201cValidation of Analytical Procedures. Geneva.\u201d"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/bmc.6002"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.18231\/j.joapr.2024.12.2.109.123"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.30904\/j.ijrpls.2025.4897"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.123.001290"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.microc.2024.110104"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.29228\/jrp.259"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ekir.2024.02.228"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265\u2010024\u201002009\u20104"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.3390\/molecules29102289"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.4274\/tjps.galenos.2023.99148"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10337\u2010025\u201004420\u20109"}],"container-title":["Biomedical Chromatography"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.70483","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/bmc.70483","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bmc.70483","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T04:52:21Z","timestamp":1778820741000},"score":1,"resource":{"primary":{"URL":"https:\/\/analyticalsciencejournals.onlinelibrary.wiley.com\/doi\/10.1002\/bmc.70483"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,6]]},"references-count":18,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2026,6]]}},"alternative-id":["10.1002\/bmc.70483"],"URL":"https:\/\/doi.org\/10.1002\/bmc.70483","archive":["Portico"],"relation":{},"ISSN":["0269-3879","1099-0801"],"issn-type":[{"value":"0269-3879","type":"print"},{"value":"1099-0801","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,6]]},"assertion":[{"value":"2026-02-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-25","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-06","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70483"}}