Apalutamide Amine Impurity

Structure-Activity Relationship for Thiohydantoin Androgen Receptor Antagonists for Castration-Resistant Prostate Cancer (CRPC)
Michael E. Jung,*,† Samedy Ouk,† Dongwon Yoo,† Charles L. Sawyers,‡,§ Charlie Chen,‡ Chris Tran,‡ and John Wongvipat
J. Med. Chem. 2010, 53, 2779–2796
 
Review of Synthetic Routes and Crystalline Forms of the Antiandrogen Oncology Drugs Enzalutamide, Apalutamide, and Darolutamide
David L. Hughes*
Org. Process Res. Dev. 2020, 24, 3, 347–362
 
Discovery of deshydroxy bicalutamide derivatives as androgen receptor antagonists
S. Kandil, K.Y. Lee, L. Davies, S.A. Rizzo, D.A. Dart, A.D. Westwell, Discovery of deshydroxy bicalutamide derivatives as androgen receptor antagonists, European Journal of Medicinal Chemistry (2019)
European Journal of Medicinal Chemistry Volume 167, 1 April 2019, Pages 49-60

Apalutamide Amine Impurity is chemically 4-((1-Cyanocyclobutyl)amino)-2-fluoro-N-methylbenzamide. Apalutamide Amine Impurity is supplied with detailed characterization data compliant with regulatory guideline. Apalutamide Amine Impurity 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 Apalutamide.

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.