Quality by design approach of a pharmaceutical gel manufacturing process, part 1: Determination of the design space

2011 ◽  
Vol 100 (10) ◽  
pp. 4432-4441 ◽  
Author(s):  
Juan G. Rosas ◽  
Marcel Blanco ◽  
Josep M. González ◽  
Manel Alcalá
Keyword(s):  
Manufacturing Process ◽  
Quality By Design ◽  
Design Space ◽  
Design Approach ◽  
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.​

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