Sofosbuvir Impurity SA15436

Sofosbuvir Impurity SA15436 product with CAS: NA is also known as {(1R)-1-[(2R,3S,4R,5R)-3,4-Dihydroxy-5-(hydroxymethyl)-3-methyltetrahydrofur-2-yl]-2-oxo-1H-pyrimidin-4-ylamino}phenylformaldehyde. 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, {(1R)-1-[(2R,3S,4R,5R)-3,4-Dihydroxy-5-(hydroxymethyl)-3-methyltetrahydrofur-2-yl]-2-oxo-1H-pyrimidin-4-ylamino}phenylformaldehyde is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.