Sofosbuvir Chloro Analog; Chloro Sofosbuvir

Sofosbuvir Chloro Analog; Chloro Sofosbuvir product with CAS: 1496552-51-2 is also known as N-[[P(S),2’R]-2’-Chloro-2’-deoxy-2’-methyl-P-phenyl-5’-uridylyl]-L-alanine 1-Methylethyl Ester. 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, N-[[P(S),2’R]-2’-Chloro-2’-deoxy-2’-methyl-P-phenyl-5’-uridylyl]-L-alanine 1-Methylethyl Ester is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.