Sorafenib EP Impurity H

Fragmentation pathways and differentiation of positional isomers of sorafenib and structural analogues by ESI-IT-MSn and ESI-Q-TOF-MS/MS coupled with DFT calculations
By Yu, Dandan; Liang, Xianrui
From Journal of Mass Spectrometry (2018), 53(7), 579-589.
 
Box-Behnken design based statistical modelling for optimization of U PLC-MS/MS method for analysis of sorafenib in bulk and tablets
By Wanii, Tanveer A.; Alanazi, Amer M.; Zargar, Seema; Ahmad, Ajaz; Drawish, Ibrahim A.
From Journal of Computational and Theoretical Nanoscience (2015), 12(10), 3598-3604

Determination of sorafenib in human plasma by HPLC
By Liu, Weifeng; Cao, Pengjian; Zhang, Chunfang; Xia, Dongxia; Che, Shujuan; Lou, Dan; Qiu, Xiangjun
From Zhongguo Xiandai Yingyong Yaoxue (2015), 32(2), 182-185

Sorafenib EP Impurity H is chemically 4-[4-[[[2-chloro-3-(trifluoromethyl)phenyl]carbamoyl]amino]phenoxy]-N-methylpyridine-2-carboxamide (as per EP); 4-(4-{3-[2-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)-N-methylpicolinamide (as per USP). It is also known as Sorafenib USP Related Compound H. Sorafenib EP Impurity H is supplied with detailed characterization data compliant with regulatory guideline. Sorafenib EP Impurity H can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Sorafenib.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.