This impurity is related to Ledipasvir Keto Impurity-1 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 Keto Impurity-1 is used as a reference standard in analytical research. It ensures consistency of formulations.
Chemical Name:((S)-1-((1R,3S,4S)-3-(6-(7-(2-((S)-5-acetyl-5-azaspiro[2.4]heptan-6-yl)-1H-imidazol-5-yl)-9,9-difluoro-9H-fluoren-2-yl)-1H-benzo[d]Country of Origin: India Product Category: Impurity Reference StandardAPI NAME: Ledipasvir Molecular Formula: C29H29BrN4O4
Molecular Weight: 577.5
Storage: Store in a cool, dry place.