l-Alanine, N-[[P(S),2'R]-2'-deoxy-2'-fluoro-2'-methyl-P-phenyl-5'-uridylyl]-, 1-methylethyl ester;
Isopropyl [(S)-{[(2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]-l-alaninate [1190307-88-0]
BRIEFING
Sofosbuvir. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed. The liquid chromatographic procedures for the Assay and the test for Organic Impurities were validated using the Symmetry C18 brand of column with L1 packing. The typical retention time for sofosbuvir is about 35 min.
This monograph is contingent on FDA approval of the product that meets the proposed monograph specifications. Please see the Pending Monograph Guideline for additional information.
Description and solubility information: White to off-white solid. Freely soluble in ethanol and acetone, soluble in isopropyl alcohol and insoluble in heptane.
(SM1: R. Radhakrishnan)
Case ID—SUB-302
USP REFERENCE STANDARDS FOR PURCHASE
USP Sofosbuvir RSUSP Sofosbuvir Related Compound A RS
USP Sofosbuvir Related Compound B RS