4-Desfluoro Sitagliptin; Sitagliptin EP Impurity B

4-Desfluoro Sitagliptin; Sitagliptin EP Impurity B product with CAS: 1345822-87-8; 486460-31-5 is also known as (R)-3-amino-4-(2,5-difluorophenyl)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one. This product can be used as a working standard or secondary reference standard. Additional internal validation as per respective FDA regulations/guidelines may require. 4-Desfluoro Sitagliptin; Sitagliptin EP Impurity B is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Sitagliptin and its related formulations. Moreover, (R)-3-amino-4-(2,5-difluorophenyl)-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.