Ketoconazole EP Impurity A

Identification and quantitation of cis-ketoconazole impurity by capillary zone electrophoresis–mass spectrometry
Mar´ıa Castro-Puyana a, Carmen Garc´ıa-Ruiz a, Alejandro Cifuentes b, Antonio L. Crego a, Maria Luisa Marina
Journal of Chromatography A, 1114 (2006) 170–177
 
Impurities contained in antifungal drug ketoconazole are potent activators of human aryl hydrocarbon receptor
Aneta Grycová , Aneta Dořičáková 1, Zdeněk Dvořák
Toxicol Lett . 2015 Dec 3;239(2):67-72
 
Ion-pairing liquid chromatographic method determination of ketoconazole and stress degradation in pharmaceutical formulations with fluorescence detection
Wisanu Thongchai
Brazilian Journal of Pharmaceutical Sciences Sci. vol.56
 
Development and Validation of Stability-Indicating Method for the Simultaneous Determination of Ketoconazole and Beauvericin in Pharmaceutical Tablets
Tingting Tian, Min Yang, Zhongxi Zhao, Yuxia Luan, Xuan Tang, Meihua Zhu, Yan Liu
Journal of Chromatographic Science, Volume 54, Issue 3, 1 March 2016, Pages 361–366

Ketoconazole EP Impurity A is chemically 1-[(52RS,54SR)-52-(2,4-dichlorophenyl)-12,13-dihydro-11H-3-oxa-1(1)-pyrazina-7(1)-imidazola-5(2,4)-[1,3]dioxolana-2(1,4)-benzenaheptaphan-11-yl]ethan-1-one (as per EP). Ketoconazole EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Ketoconazole EP Impurity A 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 Ketoconazole.

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.