Gefitinib 3,4-Difluoro Impurity HCl

Identification, characterization and HPLC quantification of formulation-related impurities of honokiol, an antitumor natural drug candidate in clinical trials
Wenshuang Wu 1,2, # , Ming-Hai Tang2, # , Huan Tang 2 , Kai Chen 2,3 , Jie Fu 4 , Lun Wang 2,3 , Lin-Lin Xue 2 , Aihua Peng 2 , Haoyu Ye 2, 4* , Li-Juan Chen
Journal of Pharmaceutical and Biomedical Analysis Volume 153, 10 May 2018, Pages 186-192
 
Separation and Estimation of Process-Related Impurities of Gefitinib by Reverse-Phase High-Performance Liquid Chromatography
Karunakara A. Chandrashekara, Aparna Udupi, Chandrasekara G. Reddy
Journal of Chromatographic Science, Volume 52, Issue 8, September 2014, Pages 799–805

Gefitinib 3,4-Difluoro Impurity HCl is chemically N-(3,4-Difluorophenyl)-7-methoxy-6-(3-morpholinopropoxy)quinazolin-4-amine hydrochloride. Gefitinib 3,4-Difluoro Impurity HCl is supplied with detailed characterization data compliant with regulatory guideline. Gefitinib 3,4-Difluoro Impurity HCl 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 Gefitinib.

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.