Acalabrutinib Impurity 11

Development and validation of novel HPLC bioanalytical analysis method for acalabrutinib: an anticancer drug in human plasma
By Krishna, G. Atchutarama; Srinivasarao, P.; Patrudu, T. Benarji; Chidanandaswamy, R.
From Asian Journal of Chemistry (2020), 32(10), 2606-2610

Development and validation of UV-​spectrophotometric method for simultaneous determination of acamprosate calcium, disulfiram and ondansetron hydrochloride in bulk and tablet dosage forms
By Patil, Purushottam R.; Wagh, Milind P.; Chaudhari, Sanjay R.
From American Journal of PharmTech Research (2016), 6(2), 655-664

Acalabrutinib Impurity 11 is chemically (S)-4-(9-(1-(But-2-ynoyl)pyrrolidin-2-yl)-4-methyl-2-oxo-2H-imidazo[5',1':3,4]pyrazino[1,2-a]pyrimidin-11-yl)-N-(pyridin-2-yl)benzamide. It is also known as Propynoic acid. Acalabrutinib Impurity 11 is supplied with detailed characterization data compliant with regulatory guideline. Acalabrutinib Impurity 11 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 Acalabrutinib.

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.