Sofosbuvir Impurity 1

Method development and validation for the simultaneous estimation of sofosbuvir and velpatasvir in bulk and tablet dosage forms by RP-HPLC
By Suma, M. S. M.; Gowthami, M.; Latha, P. V. Madhavi; Devi, P. Uma
From Journal of Global Trends in Pharmaceutical Sciences (2021), 12(1), 9037-9043.
 
Development and validation of RP-HPLC method for the estimation of Sofosbuvir and Ledipasvir in combined dosage form
By Prabhaker, Naik Desai Prabhat; Pankaj, Kapupara
From International Journal of Research in Pharmaceutical Sciences (Madurai, India) (2021), 12(1), 523-529.
 
Eco-friendly HPTLC method for simultaneous analysis of sofosbuvir and ledipasvir in biological and pharmaceutical samples: Stability indicating study
By El-Yazbi, Amira F.; Elashkar, Nourhan E.; Abdel-Hay, Karim M.; Talaat, Wael; Ahmed, Hytham M.
From Microchemical Journal (2020), 154, 104584.
 

Sofosbuvir Impurity 1 is chemically (3R,4R,5R)-3-Fluoro-4-hydroxy-5-(hydroxymethyl)-3-methyldihydrofuran-2(3H)-one. Sofosbuvir Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Sofosbuvir 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 Sofosbuvir.

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.