Sitagliptin Fumarate Adduct

Sitagliptin Fumarate Adduct product with CAS: 2088771-60-0 is also known as (R)-Sitagliptin rac-Fumarate Adduct (mixture of diastereomers); Sitagliptin Tablets EP Impurity FP-A; 2-(((R)-4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-1-(2,4,5-trifluorophenyl)butan-2-yl)amino)succinic acid. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. Sitagliptin Fumarate Adduct is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Sitagliptin and its related formulations. Moreover, 2-(((R)-4-oxo-4-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)-1-(2,4,5-trifluorophenyl)butan-2-yl)amino)succinic acid is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.