{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T05:56:04Z","timestamp":1789106164188,"version":"build-2803163510"},"reference-count":27,"publisher":"SAGE Publications","issue":"1-2","license":[{"start":{"date-parts":[[2025,2,1]],"date-time":"2025-02-01T00:00:00Z","timestamp":1738368000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Eur J Mass Spectrom (Chichester)"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:p>\n                    Rimegepant is a calcitonin gene-related peptide receptor antagonist that has been licensed for migraine headache treatment in the United States, the European Union, the United Kingdom, Hong Kong, Australia, and Kuwait. The oxidation stress study of the Rimegepant drug substance revealed the presence of five impurities. Rimegepant degraded by 5% under the selected oxidation conditions, meeting regulatory expectations. Four out of five impurities are enhanced by more than 1%. This research aims to characterize these oxidation degradation products utilizing the triple quadrupole mass spectroscopic technique. The Rimegepant oxidation degradation products were identified using an optimized chromatographic method that relies on reverse-phase HPLC with PDA detection. This technique utilized a Waters Xbridge C18 column with an eluent mixture of acetonitrile and 0.1% formic acid in water. The oxidation products of Rimegepant have been effectively separated, with a resolution above 3.0. Triple quadrupole mass spectrometry analysis characterized the five degradation products, which showed three N-oxide impurities with masses\n                    <jats:italic>m<\/jats:italic>\n                    \/\n                    <jats:italic>z<\/jats:italic>\n                    566,\n                    <jats:italic>m<\/jats:italic>\n                    \/\n                    <jats:italic>z<\/jats:italic>\n                    550, and\n                    <jats:italic>m<\/jats:italic>\n                    \/\n                    <jats:italic>z<\/jats:italic>\n                    548, as well as two hydrolysis products with masses,\n                    <jats:italic>m<\/jats:italic>\n                    \/\n                    <jats:italic>z<\/jats:italic>\n                    218,\n                    <jats:italic>m<\/jats:italic>\n                    \/\n                    <jats:italic>z<\/jats:italic>\n                    290. These new impurities deserve special attention because the drug's potency and related impurity levels determine any pharmaceutical medication product's quality, safety, and effectiveness.\n                  <\/jats:p>","DOI":"10.1177\/14690667251328804","type":"journal-article","created":{"date-parts":[[2025,3,26]],"date-time":"2025-03-26T18:38:53Z","timestamp":1743014333000},"page":"38-50","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["Identification and characterization of unknown oxidation degradation products of Rimegepant by HPLC and triple quadrupole mass spectrometry"],"prefix":"10.1177","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-6654-9733","authenticated-orcid":false,"given":"Narayana Reddy","family":"Godi","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Analysis, School of Pharmacy, Anurag University, Hyderabad, Telangana, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9315-9085","authenticated-orcid":false,"given":"Sireesha","family":"Dodda","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Analysis, School of Pharmacy, Anurag University, Hyderabad, Telangana, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4333-8995","authenticated-orcid":false,"given":"Nagavardhana Reddy","family":"Vanga","sequence":"additional","affiliation":[{"name":"Industrial Chemical Product Development and Analysis Centre, Department of Chemistry, GITAM School of Science, GITAM Deemed to be University \u2013 Bengaluru Campus, Bengaluru, Karnataka, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9539-2382","authenticated-orcid":false,"given":"Kumarswamy","family":"Ummiti","sequence":"additional","affiliation":[{"name":"Department of Chemistry, College of Engineering, Koneru Lakshmaiah Education Foundation, Guntur, Andhra Pradesh, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,3,26]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/head.13930"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1811090"},{"key":"e_1_3_3_4_2","unstructured":"NURTEC ODT (Rimegepant) orally disintegrating tablets for sublingual or oral use. U.S. Food and Drug Administration Silver Spring. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/212728s006lbl.pdf. (2020 accessed 16 September 2024)."},{"key":"e_1_3_3_5_2","unstructured":"Vydura (Rimegepant). European Medicines Agency. https:\/\/www.ema.europa.eu\/en\/documents\/overview\/vydura-epar-medicine-overview_en.pdf. (2022 accessed 04 October 2024)."},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-020-01264-5"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1358\/dot.2020.56.7.3157311"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.2174\/1573412914666181024150632"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.2174\/1573412911666150519000155"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1080\/10826076.2013.836712"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.31788\/RJC.2022.1516707"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1093\/jaoacint\/qsae057"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1093\/chromsci\/bmv029"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2024.116117"},{"key":"e_1_3_3_15_2","unstructured":"Impurities In New Drug Products Q3B(R2). ICH Harmonised Tripartite Guideline. https:\/\/database.ich.org\/sites\/default\/files\/Q3B%28R2%29%20Guideline.pdf. (2006 accessed 9 November 2024)."},{"key":"e_1_3_3_16_2","unstructured":"Office of Pharmaceutical Quality. Establishing Impurity Acceptance Criteria as Part of Specifications for NDAs ANDAs and BLAs Based on Clinical Relevance. Manual of Policies and Procedures; MAPP 5017.2 Rev. 1. https:\/\/www.fda.gov\/media\/124859\/download. (2020 accessed 29 October 2024)."},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1177\/14690667211005335"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.4236\/ajac.2016.711073"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1093\/chromsci\/bmad016"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1177\/14690667241262935"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.9734\/jpri\/2021\/v33i431170"},{"key":"e_1_3_3_22_2","first-page":"3628","article-title":"A novel validated RP-HPLC method development for the quantitative determination of rimegepant in BulkForm and marketed pharmaceutical dosage form","volume":"11","author":"Mahesh M","year":"2023","unstructured":"Mahesh M, Sammaiah G. A novel validated RP-HPLC method development for the quantitative determination of rimegepant in BulkForm and marketed pharmaceutical dosage form. 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