Tridesfluoro benzene diamide Sitagliptin impurity

Tridesfluoro benzene diamide Sitagliptin impurity product with CAS: NA is also known as (R)-3-amino-N-((R)-4-oxo-1-phenyl-4-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-2-yl)-4-(2,4,5-trifluorophenyl)butanamide. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. Tridesfluoro benzene diamide Sitagliptin impurity is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Sitagliptin and its related formulations. Moreover, (R)-3-amino-N-((R)-4-oxo-1-phenyl-4-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-2-yl)-4-(2,4,5-trifluorophenyl)butanamide is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.