Remdesivir Impurity 46

Remdesivir for the treatment of COVID-​19
By Ansems Kelly; Dahms Karolina; Benstoem Carina; Grundeis Felicitas; Mikolajewska Agata; Stegemann Miriam; Thieme Volker; Fichtner Falk; Piechotta Vanessa; Metzendorf Maria-Inti
From The Cochrane database of systematic reviews (2021), 8, CD014962
 

Remdesivir Impurity 46 is chemically 2-Ethylbutyl ((S)-(((2R,3S,4R,5S)-5-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-carbamoyl-3,4-dihydroxytetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)-L-alaninate. Remdesivir Impurity 46 is supplied with detailed characterization data compliant with regulatory guideline. Remdesivir Impurity 46 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 Remdesivir.

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.