Sacubitril Impurity 81

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
 
Quantification of potential genotoxic impurity in sacubitril/valsartan drug substance at ppm level by LC-MS/MS
Ravi Uppala, M.Arthanareeswari, S.Devikala,T.Pushpamalini, J. ArockiaSelvi
Materials Today: Proceedings Volume 14, Part 2, 2019, Pages 640-645
 
Experimental Design Approach in HPLC Method Development: Application for the Simultaneous Determination of Sacubitril and Valsartan in Presence of Their Impurities and Investigation of Degradation Kinetics
Bahia A. Moussa, Hanaa M. A. Hashem, Marianne A. Mahrouse & Sally T. Mahmoud
Chromatographia volume 81, pages139–156(2018)
 
Development and validation of a stability indicating UHPLC method for Sacubitril/Valsartan complex in the presence of impurities and degradation products
Pintu Prajapati, Dhara Bhayani, Priti Mehta.
J App Pharm Sci. 2020; 10(2): 97-107

Sacubitril Impurity 81 is chemically Ethyl 5-([1,1'-biphenyl]-4-yl)-4-((tert-butoxycarbonyl)amino)-2-methylpentanoate. Sacubitril Impurity 81 is supplied with detailed characterization data compliant with regulatory guideline. Sacubitril Impurity 81 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 Sacubitril.

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.