Brexpiprazole Impurity 58

Development and validation of stability indicating RP-​HPLC method for estimation of Brexpiprazole in tablet
By Jaiswal, Chandrakant C.; Patel, Harsha U.
From World Journal of Pharmacy and Pharmaceutical Sciences (2020), 9(6), 1568-1582

 
Stability indicating TLC method for quantification of Brexpiprazole in bulk and its pharmaceutical dosage form and determination of content uniformity
By Thakkar, Anjali M.; Chhalotiya, Usmangani K.; Parekh, Nikunj; Desai, Jaineel V.; Shah, Dimal A.
From Journal of Chromatographic Science (2019), 57(7), 644-652
 
A new stability indicating RP-​HPLC method for estimation of brexpiprazole
By Kumar, Vanapalli Goutham; Mondal, Sumanta
From Journal of Drug Delivery and Therapeutics (2019), 9(2Suppl.), 214-222

Brexpiprazole Impurity 58 is chemically Di-tert-butyl piperazine-1,4-dicarboxylate. Brexpiprazole Impurity 58 is supplied with detailed characterization data compliant with regulatory guideline. Brexpiprazole Impurity 58 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 Brexpiprazole.

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.