Use of the hyphenated LC-MS/MS technique and NMR/IR spectroscopy for the identification of exemestane stress degradation products during the drug development

Exemestane (6-Methyleneandrosta-1,4-diene-3,17-dione) active pharmaceutical ingredient (EE-3) was subjected to thermal, photolytic, oxidative, acidic and base stress conditions prescribed by the ICH (International Conference on Harmonization) guideline Q1A(R2). EE-3 was found to degrade in base, aci...

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Veröffentlicht in:European journal of pharmaceutical sciences 2017-11, Vol.109, p.389-401
Hauptverfasser: Stolarczyk, Elżbieta U., Rosa, Anna, Kubiszewski, Marek, Zagrodzka, Joanna, Cybulski, Marcin, Kaczmarek, Łukasz
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Sprache:eng
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