Identification and structural characterization of four novel degradation products and a process impurity of isavuconazonium sulfate for injection formulation bulk by LC-ESI-QTOF-MS/MS
Keyword(s):
Isavuconazonium sulfate is a highly water-soluble pro-drug of active triazole isavuconazole. The degradation profile of isavuconazonium sulfate for injection formulation bulk under acid hydrolysis, alkaline hydrolysis, oxidation, heat, and light conditions was studied using LC-PDA/MS technique. Four degradation products (DP1 to DP4) and one process impurity (PI1) were identified in isavuconazonium sulfate formulation bulk and characterized the identified impurities by liquid chromatography-electron spray ionization-quadruple-time of flight tandem mass spectrometry. Isavuconazole (DP1) was found to be one of the major degradation products of isavuconazonium sulfate.
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2016 ◽
Vol 39
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pp. 558-567
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2008 ◽
Vol 873
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pp. 165-172
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