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Furthermore, there is a lack of comprehensive discussion evaluating how different commercially available formulations influence the overall efficacy of MSP, even though reports indicate issues with the quality of these formulations, particularly regarding stability and vaginal absorption processes. This study investigates the stability of MSP under acidic conditions and its in vitro permeation using swine vaginal mucosa. A forced degradation study was conducted using 0.2 M HCl, and a high\u2010efficiency LC method was developed. Three degradation products were identified and characterized using electrospray ionization\u2013high\u2010resolution quadrupole\u2010time\u2010of\u2010flight\u2013MS, with respective <jats:italic>m\/z<\/jats:italic> values of 391.2508, 405.2705, and 387.2259, respectively. These results suggest that the degradation mechanism involves dehydration of the \u03b2\u2010hydroxy ketone moiety, followed by isomerization to its most resonance\u2010stable form and de\u2010esterification. Finally, the in vitro permeation study revealed that the esterified form of MSP was unable to permeate the mucosa and required prior degradation for any component to be detected in the receptor fluid.<\/jats:p>","DOI":"10.1002\/bmc.5897","type":"journal-article","created":{"date-parts":[[2024,5,30]],"date-time":"2024-05-30T01:59:57Z","timestamp":1717034397000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Development and validation of a stability\u2010indicating method, structural elucidation of new degradation products from misoprostol by LC\u2013MS time\u2010of\u2010flight, and an ex vivo study of vaginal permeation"],"prefix":"10.1002","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0604-1025","authenticated-orcid":false,"given":"Jos\u00e9 Wellithom Viturino","family":"da Silva","sequence":"first","affiliation":[{"name":"Pharmaceutical and Cosmetic Development Center (NUDFAC) Federal 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