N,N’-(ethane-1,2-diyl)bis(3-amino-4-(2,4,5-trifluorophenyl)butanamide)dihydrochloride

N,N’-(ethane-1,2-diyl)bis(3-amino-4-(2,4,5-trifluorophenyl)butanamide)dihydrochloride product with CAS: NA is also known as 4-(2-((R)-3-ammonio-4-(2,4,5-trifluorophenyl)butanamido)ethylamino)-4-oxo-1-(2,4,5-trifluorophenyl)butan-2-aminium chloride. 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 Sitagliptin impurity profiling as per limits and threshold values specified by respective drug legislation, FDA, and pharmacopoeial guidelines. Moreover, 4-(2-((R)-3-ammonio-4-(2,4,5-trifluorophenyl)butanamido)ethylamino)-4-oxo-1-(2,4,5-trifluorophenyl)butan-2-aminium chloride is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.