Abiraterone Impurity 8

Identification, Characterization and HighPerformance Liquid Chromatography Quantification for Process-Related Impurities in Abiraterone Acetate Bulk Drug
Changjie Hu, Hanqiao Zhang, Menglin Zhang, Zhiyuan Mi, Jun Wang, Wenpin Lu, and Jiangtao Su*
Journal of Chromatographic Science, Volume 56, Issue 9, October 2018, Pages 802–811
 
stability indicating rp-hplc-pda method for determination of abiraterone acetate and characterization of its base catalyzed degradation product by lc-ms
Department of Quality Assurance Techniques, maeer’S Maharashtra Institute of Pharmacy, MIT Campus, Kothrud, Pune 411038
International Journal of Pharmacy and Pharmaceutical Sciences, Vol 8, Issue 2, 2016

Abiraterone Impurity 8 is chemically (3S,10R,13S)-10,13-Dimethyl-17-(trifluoromethylsulfonyloxy)-2,3,4,7,8,9,10,11,12,13,14,15-dodecahydro-1Hcyclopenta[a]phenanthren-3-yl 2,2,2-trifluoroacetate. Abiraterone Impurity 8 is supplied with detailed characterization data compliant with regulatory guideline. Abiraterone Impurity 8 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 Abiraterone Acetate.

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.