2′-Keto Sofosbuvir

2′-Keto Sofosbuvir product with CAS: NA is also known as isopropyl ((S)-(((2R,3R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-3-hydroxy-4-oxotetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)-L-alaninate. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. It is used in Sofosbuvir impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, isopropyl ((S)-(((2R,3R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-3-hydroxy-4-oxotetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)-L-alaninate is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.