Enzalutamide Impurity 15

Structural elucidation of the impurities in Enzalutamide bulk drug and the development, validation of corresponding HPLC method
Xingling Mab , Wentao Zhoua , Qiaogen Zoua,*, Pingkai Ouyang
Journal of Pharmaceutical and Biomedical Analysis Volume 131, 30 November 2016, Pages 436-443
 
Crystal Forms of Enzalutamide and a Crystal Engineering Route to Drug Purification
Lucia Maini, Dario Braga, Francesco Farinella, Elisa Melotto, Massimo Verzini, Roberto Brescello, Ivan Michieletto, and Ilaria Munari
Cryst. Growth Des. 2018, 18, 7, 3774–3780
 
Quantitative Study of Impurities in Enzalutamide and Identification, Isolation, Characterization of Its Four Degradation Products Using HPLC, Semi-preparative LC, LC/ESI–MS and NMR Analyses
Ainan Zhou1,2 · Lejun Ruan1  · Gengli Duan2  · Jianqi Li
Chromatographia volume 81, pages1519–1531(2018)
 
Validation of a method for quantifying enzalutamide and its major metabolites in human plasma by LC–MS/MS
Daniel Bennett, Jacqueline A Gibbons, Roelof Mol, Yoshiaki Ohtsu & Clark Williard
Bioanalysis (2014) 6(6), 737–744

Enzalutamide Impurity 15 is chemically 2-Aminoisobutyric acid. Enzalutamide Impurity 15 is supplied with detailed characterization data compliant with regulatory guideline. Enzalutamide Impurity 15 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 Enzalutamide.

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.