This impurity is related to Ketoconazole is provided with comprehensive characterization data in accordance with regulatory guidelines. It is suitable for use in analytical method development, method validation (AMV), Quality Control (QC) applications for Abbreviated New Drug Applications (ANDA) and commercial production of Asenapine.
Ketoconazole is used as a reference standard in analytical research. It ensures consistency of formulations.
Chemical Name:1-[(52RS,54SR)-52-(2,4-Dichlorophenyl)-3-oxa-1(1)-piperazina-7(1)-imidazola-5(2,4)-[1,3]dioxolana-2(1,4)-benzenaheptaphan-11-yl]ethan-1-one (as er EP) ; (?)-cis-1-Acetyl-4-(p-[[2-(2,4-dichlorophenyl)-2-(imidazol-1- ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl)piperazineCountry of Origin: India Product Category: Impurity Reference StandardAPI NAME: Ketoconazole Molecular Formula: C26H28Cl2N4O4
Molecular Weight: 531.4
Storage: Store in a cool, dry place.