Valsartan Impurity 8 (Impurity B)

Identification and characterization of potential impurities of valsartan, AT1 receptor antagonist
A.Sampath, A. Raghupathi Reddy, B.Yakambaram, A.Thirupathi, M.Prabhakar, P. Pratap Reddy, V. Prabhakar Reddy
Journal of Pharmaceutical and Biomedical Analysis Volume 50, Issue 3, 15 October 2009, Pages 405-412
 
Monitoring of Impurity Level of Valsartan and Hydrochlorothiazide Employing an RP–HPLC Gradient Mode
Darko Ivanović,Anđelija Malenović,Biljana Jančić,Prof. Dr. Mirjana Medenica  &Marija Mašković
Journal of Liquid Chromatography & Related Technologies  Volume 30, 2007 - Issue 19 Pages 2879-2890
 
A liquid chromatographic method for separation of sacubitril–valsartan and their stereoisomeric impurities
Lu Zhou, Liang Zou, Lili Sun, Hui Zhang, Wenkai Hui and  Qiaogen Zou
Anal. Methods, 2018,10, 1046-1053

Valsartan Impurity 8 (Impurity B) is chemically (S)-Methyl 2-(((2’-cyano-[1,1’-biphenyl]-4-yl)methyl)amino)-3-methylbutanoate Hydrochloride Salt. Valsartan Impurity 8 (Impurity B) is supplied with detailed characterization data compliant with regulatory guideline. Valsartan Impurity 8 (Impurity B) 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 Valsartan .

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.