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

被引：2
|
作者：
Regella, Venkata Rama Prabhakara Sastry [1 ]
Subramanian, Venkatesan Chidambaram [1 ]
Bhetanabhotla, Sarveswara Sastry [1 ]
机构：
[1] Gland Pharma Ltd, Res & Dev, Hyderabad 500043, Telangana, India
来源：
EUROPEAN JOURNAL OF MASS SPECTROMETRY | 2020年 / 26卷 / 02期
关键词：
Characterization; degradation products; isavuconazonium sulfate; LC-PDA; MS; tandem mass spectrometry; degradation profile; PRODRUG;
D O I：
10.1177/1469066719884402
中图分类号：
O64 [物理化学（理论化学）、化学物理学]; O56 [分子物理学、原子物理学];
学科分类号：
070203 ; 070304 ; 081704 ; 1406 ;
摘要：
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.
引用
收藏
页码：144 / 152
页数：9
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