This impurity is related to Ledipasvir Impurity 21 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.
Ledipasvir Impurity 21 is used as a reference standard in analytical research. It ensures consistency of formulations.
Chemical Name:6-(7-(2-((S)-5-azaspiro[2.4]heptan-6-yl)-1H-imidazol-5-yl)-9,9-difluoro-9H-fluoren-2-yl)-2-((1R,3S,4S)-2-azabicyclo[2.2.1]heptan-3-yl)-1H-benzo[d]imidazole tetrahydrochlorideCountry of Origin: India Product Category: Impurity Reference StandardAPI NAME: Ledipasvir Molecular Formula: C35H32F2N6 : 4(HCl)
Molecular Weight: 574.7 : 4(36.5)
Storage: Store in a cool, dry place.