Quality risk assessment and DoE-based analytical quality by design approach to stability-indicating assay method for acidic degradation kinetic study of apremilast

2020 ◽  
Vol 33 (3) ◽  
pp. 231-244
Author(s):  
Pintu Prajapati ◽  
Hitika Patel ◽  
Shailesh Shah
Keyword(s):  
Risk Assessment ◽  
Kinetic Study ◽  
Quality By Design ◽  
Design Approach ◽  
Assay Method ◽  
Analytical Quality ◽  
Degradation Kinetic ◽  
Stability Indicating ◽  
Quality By Design Approach ◽  
Acidic Degradation

Analytical Quality by Design Approach for a Stability-Indicating Method to Determine Apixaban and Its Related Impurities

2019 ◽  
Vol 83 (1) ◽  
pp. 65-75 ◽  
Author(s):  
Jéssica B. Ellwanger ◽  
Nathalie Ribeiro Wingert ◽  
Nadia Maria Volpato ◽  
Cássia Virginia Garcia ◽  
Elfrides E. S. Schapoval ◽  
...  
Keyword(s):  
Quality By Design ◽  
Design Approach ◽  
Analytical Quality ◽  
Stability Indicating ◽  
Related Impurities ◽  
Stability Indicating Method ◽  
Quality By Design Approach

scholarly journals A stability-indicating method for Levetiracetam in tablets using advanced analytical quality-by-design approach ‎

2021 ◽  
Vol 11 (3) ◽  
pp. 126-131
Author(s):  
Maher Abdulrazzaq Al-hakeem ◽  
Lacramioara Popa ◽  
Cristina Dinu-Pirvu ◽  
Mihaela Violeta Ghica ◽  
Razvan Prisada
Keyword(s):  
Quality By Design ◽  
Design Approach ◽  
Analytical Quality ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Quality By Design Approach

Using an innovative quality-by-design approach for the development of a stability-indicating UPLC/Q-TOF-ESI-MS/MS method for stressed degradation products of imatinib mesylate

RSC Advances ◽  
2016 ◽  
Vol 6 (16) ◽  
pp. 13050-13062 ◽  
Author(s):  
Zhihui Ren ◽  
Xiaoxi Zhang ◽  
Haiyuan Wang ◽  
Xinghua Jin
Keyword(s):  
Simultaneous Determination ◽  
Imatinib Mesylate ◽  
Quality By Design ◽  
Degradation Products ◽  
Design Approach ◽  
Design Expert ◽  
Stability Indicating ◽  
Esi Ms ◽  
Quality By Design Approach

Chromatography modeling softwares (DryLab®2000 plus and Design Expert®​8.0.6) were used to develop a stability indicating UPLC/Q-TOF-ESI-MS/MS method for the simultaneous determination of stressed degradation products of imatinib mesylate.​

Sign in / Sign up

Export Citation Format

Share Document