Velpatasvir Impurity 16

UPLC Separation of forced degradation and process related impurities of Velpatasvir and structure elucidation by online LC-Quadrupole-Time of flight-Tandem mass Spectrometry
Md. Sattar Abdul*, Suneetha A.Research Journal of Pharmacy and Technology
Year : 2019, Volume : 12, Issue : 2
First page : ( 477) Last page : ( 482)

Stability indicating RP-HPLC Method development and Validation for the Estimation of Sofosbuvir, Velpatasvir and Voxilaprevir in Bulk and Pharmaceutical dosage form
Kokkirala, Tej Kumar; Suryakala, Duvvuri. Research Journal of Pharmacy and Technology; RaipurVol. 13, Iss. 11, (Nov 2020): 5063-5071. DOI:10.5958/0974-360X.2020.00887.2

RP-HPLC Method Development and Validation for Velpatasvir and Voxilaprevir by Simultaneous Determination in Bulk and Their Pharmaceutical Dosage Forms
DebasishSwainaAmrej SinghYadavaChandrasekharSasapuaVenkatakrishnaAkulabGananadhamuSamanthulaa
Microchemical JournalVolume 155, June 2020, 104657

Velpatasvir Impurity 16 is chemically (2R,5S)-1-((Methoxycarbonyl)-D-valyl)-5-methylpyrrolidine-2-carboxylic acid. Velpatasvir Impurity 16 is supplied with detailed characterization data compliant with regulatory guideline. Velpatasvir Impurity 16 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 Velpatasvir.

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.