Stress degradation study on entrectinib and characterization of its degradation products using HRMS and NMR

Author(s):  
Vivek Dhiman ◽  
Saranjit Singh ◽  
Ankit Balhara ◽  
Bhoopendra Singh Kushwah ◽  
Laximan Velip ◽  
...  
RSC Advances ◽  
2015 ◽  
Vol 5 (85) ◽  
pp. 69273-69288 ◽  
Author(s):  
Pradipbhai D. Kalariya ◽  
Prinesh N. Patel ◽  
Mahesh Sharma ◽  
Prabha Garg ◽  
R. Srinivas ◽  
...  

Forced degradation study of blonanserin and structural elucidation of its degradation products was performed using high resolution tandem mass spectrometry.


2021 ◽  
Author(s):  
Suresh U ◽  
Roshan M Borkar ◽  
G. Shankar ◽  
Aishwarya Jala ◽  
T Sony ◽  
...  

Bortezomib (BTZ) is a first in class, potent reversible inhibitor of proteasome used in the treatment of multiple myeloma, the second most common hematological cancer. Stress degradation studies were performed...


2020 ◽  
Vol 16 (8) ◽  
pp. 1130-1139
Author(s):  
Singaram Sathiyanarayanan ◽  
Chidambaram Subramanian Venkatesan ◽  
Senthamaraikannan Kabilan

Background: Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator and commonly used as a pharmacologic cardiac stressing agents. Methods: HPLC method was used for the analysis of related substances. The degraded impurities during the process were isolated and characterized by IR, Mass and NMR spectral analysis. Results: Forced degradation study of regadenoson under conditions of hydrolysis (neutral, acidic and alkaline) and oxidations suggested in the ICH Q1A(R2) was accomplished. The drug showed significant degradation under all the above conditions. On the whole, five novel degradation products were found under diverse conditions along with process related impurities which were not reported earlier. Conclusion: All the degradation products were well characterized by using advanced spectroscopic techniques like IR, 1H NMR, 13C NMR and Mass spectra. The identification of these impurities will be productive for the quality control during the production and stability behavior of the regadenoson drug substance.


2019 ◽  
Vol 43 (19) ◽  
pp. 7294-7306 ◽  
Author(s):  
G. Shankar ◽  
Roshan M. Borkar ◽  
Suresh Udutha ◽  
M. Kanakaraju ◽  
G. Sai Charan ◽  
...  

Omeprazole (OMP), a prototype proton pump inhibitor used for the treatment of peptic ulcers and gastroesophageal reflux disease (GERD), was subjected to forced degradation studies as per ICH guidelines Q1A (R2).


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