Synthesis and control of process-related impurities in the β-lactamase inhibitor drug substance zidebactam

被引：1

作者：

Pund, Amit A. ^{[1
]}

Rane, Vipul P. ^{[1
]}

Raut, Vivek T. ^{[1
]}

Ahirrao, Vinod K. ^{[1
]}

Yeole, Ravindra D. ^{[1
]}

Joshi, Sanjeev ^{[1
]}

Bhavsar, Satish ^{[1
]}

Rafeeq, Mohammad ^{[1
]}

Yadav, Ramprasad ^{[1
]}

Merwade, Arvind Y. ^{[1
]}

机构：

[1] Wockhardt Res Ctr, MIDC, Chikalthana, D-4, Aurangabad, India

来源：

SYNTHETIC COMMUNICATIONS | 2023年 / 53卷 / 13期

关键词：

beta-lactamase inhibitor; impurities; stereoisomer; zidebactam;

D O I：

10.1080/00397911.2023.2209677

中图分类号：

O62 [有机化学];

学科分类号：

070303 ; 081704 ;

摘要：

Zidebactam is a novel extended spectrum beta-lactamase inhibitor (ESBLI). It's combination with cefepime (WCK 5222) is in phase III clinical studies. Five process impurities were found in zidebactam (1) drug substance using process development through reverse phase high performance liquid chromatography (HPLC) method. To give access to the reference standards for the impurity profile of the drug substance as well as the final product, these process impurities of compound 1, have been synthesized and characterized. [GRAPHICS] .

引用

页码：1041 / 1052

页数：12

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