Sunitinib N-Desethyl N-Butoxycarbonyl Impurity

Sunitinib N-Desethyl N-Butoxycarbonyl Impurity is chemically N-[2-(N-Tert-Butoxycarbonylethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide ;    . Sunitinib N-Desethyl N-Butoxycarbonyl Impurity is supplied with detailed characterization data compliant with regulatory guideline. Sunitinib N-Desethyl N-Butoxycarbonyl 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 Sunitinib .

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.

Physicochemical characteristics of sunitinib malate and its process-related impurities
Katarzyna Sidoryk 1, Maura Malińska, Krzysztof Bańkowski, Marek Kubiszewski, Marta Łaszcz, Magdalena Bodziachowska-Panfil, Magdalena Kossykowska, Tomasz Giller, Andrzej Kutner, Krzysztof Woźniak
J Pharm Sci. 2013 Feb;102(2):706-16.
 
Development and validation of a HPTLC method for analysis of Sunitinib malate
Monireh Hajmalek, Masoumeh Goudarzi , Solmaz Ghaffari,Hossein Attar, Mehrnoosh Ghanbari Mazlaghan
Brazilian Journal of Pharmaceutical Sciences vol. 52, n. 4, oct./dec., 2016
 
Reverse phase HPLC determination of sunitinib malate using UV detector, its isomerisation study, method development and validation
Mohsen Padervand, Solmaz Ghaffari, Hossein Attar & Mahdieh Mohammad Nejad
Journal of Analytical Chemistry volume 72, pages567–574(2017)

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