Ledipasvir Keto Impurity-1

Insights into the Dissolution Behavior of Ledipasvir-Copovidone Amorphous Solid Dispersions: Role of Drug Loading and Intermolecular Interactions
Chailu Que, Xiaochun Lou, Dmitry Y. Zemlyanov, Huaping Mo, Anura S. Indulkar, Yi Gao, Geoff G.Z. Zhang, and Lynne S. Taylor
Mol. Pharmaceutics 2019, 16, 12, 5054–5067
 
A green stability-indicating RP-HPLC-UV method using factorial design for determination of ribavirin, sofosbuvir and ledipasvir: Application to average content, acid degradation kinetics and in vitro drug interactions study
Hanan I.EL-ShorbagyacFawziElsebaeiaSherin F.HammadbAmina M.El-Brashy
Microchemical Journal Volume 158, November 2020, 105251
 
Simultaneous chromatographic analysis of Sofosbuvir/Ledipasvir in their combined dosage form: an application to green analytical chemistry
Ahmed Hemdan & Maya S. Eissa
Journal of Analytical Science and Technology volume 10, Article number: 39 (2019)
 
Chemometrically Assisted RP-HPLC and Spectroscopic Method Development for Simultaneous Multi-Component Analysis of Ledipasvir and Sofosbuvir in Pure and Pharmaceutical Formulation
Roma N Trivedi1* , Jinal N Tandel2 , Rashmika C Patel2 , Samir K Shah2
Der Pharmacia Lettre, 2018, 10 [3]: 62-75

Ledipasvir Keto Impurity-1 is chemically Methyl ((S)-1-((S)-6-(5-(7-bromo-9-oxo-9H-fluoren-2-yl)-1H-imidazol-2-yl)-5-azaspiro[2.4]heptan-5-yl)-3-methyl-1-oxobutan-2-yl)carbamate. Ledipasvir Keto Impurity-1 is supplied with detailed characterization data compliant with regulatory guideline. Ledipasvir Keto Impurity-1 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 Ledipasvir.

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.