This impurity is related to Metabolite M1 (hydroxymethyl-Ivacaftor) 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.
Metabolite M1 (hydroxymethyl-Ivacaftor) is used as a reference standard in analytical research. It ensures consistency of formulations.
Chemical Name:N-(2-(Tert-butyl)-5-hydroxy-4-(2-hydroxypropan-2-yl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamideCountry of Origin: India Product Category: Impurity Reference StandardAPI NAME: Ivacaftor Molecular Formula: C23H26N2O4
Molecular Weight: 394.5
Storage: Store in a cool, dry place.