analytical assay
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2022 ◽  
pp. 132052
Author(s):  
Thangavelu Kokulnathan ◽  
Ramakrishnan Vishnuraj ◽  
Shen-Ming Chen ◽  
Biji Pullithadathil ◽  
Faheem Ahmed ◽  
...  

2021 ◽  
Vol 345 ◽  
pp. 128816
Author(s):  
Yujie Wang ◽  
Menghui Li ◽  
Luqing Li ◽  
Jingming Ning ◽  
Zhengzhu Zhang

2020 ◽  
Vol 11 (1) ◽  
Author(s):  
Dhruvisha Pokar ◽  
Amit Kumar Sahu ◽  
Pinaki Sengupta

AbstractVenetoclax is a selective orally active Bcl-2 protein inhibitor very recently approved by USFDA to treat chronic lymphocytic leukemia and other hematological malignancies. Postmarketing surveillance of any drug depends on its acceptability based on risk to benefit ratio. When risk outweighs the benefits, withdrawal of an already marketed drug is warranted. Presence of impurity is the primary cause of increased risk in a drug substance or drug product. With the discovery of newer molecules, it is of great importance to establish advanced analytical techniques for quantification of the drugs as well as their related impurities to address the prospective regulatory queries even if it is already in the market. In this study, a quantitative analytical assay method has been developed and validated for quantification of venetoclax in presence of its degradation impurities. A stress study was performed to examine the stability of the drug in hydrolytic, oxidative, thermolytic and photolytic environments. Venetoclax was found to be prone to degradation in acidic hydrolytic and oxidative stress conditions. Three new degradation impurities have been identified and characterized with the help of LC-Q-TOF-MS with accurate mass measurement and their putative structures have been proposed. Furthermore, for the first time, a possible degradation pathway has been established with mechanistic explanation. Moreover, the analytical method developed in this study will be of immense help for routine analysis of quality control and stability study samples of venetoclax in industry and research laboratories.


2020 ◽  
Vol 92 (17) ◽  
pp. 11879-11887
Author(s):  
Hans C. Cooper ◽  
Yuhong Xie ◽  
Giuseppe Palladino ◽  
John R. Barr ◽  
Ethan C. Settembre ◽  
...  

2020 ◽  
Vol 8 (22) ◽  
pp. 4950-4961 ◽  
Author(s):  
Elena Costa ◽  
Estela Climent ◽  
Kornelia Gawlitza ◽  
Wei Wan ◽  
Michael G. Weller ◽  
...  

An in-depth study of the chemical tuning modes of antibody-gated indicator delivery (gAID) systems revealed the importance of size matching, localisation of grafting and loading sequence for obtaining high-performance small-molecule sensor materials.


Talanta ◽  
2019 ◽  
Vol 204 ◽  
pp. 576-585 ◽  
Author(s):  
Noemí León-Roque ◽  
Silvana Aguilar-Tuesta ◽  
Juan Quispe-Neyra ◽  
Wile Mamani-Navarro ◽  
Sarela Alfaro-Cruz ◽  
...  

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