N-Boc Sitagliptin Acid Impurity

N-Boc Sitagliptin Acid Impurity product with CAS: 486460-00-8 is also known as (R)-3-(tert-butoxycarbonylamino)-4-(2,4,5-trifluorophenyl)butanoic 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. N-Boc Sitagliptin Acid Impurity is generally used for Quality Control (QC), Quality Assurance (QA) during commercial production of Sitagliptin and its related formulations. Moreover, (R)-3-(tert-butoxycarbonylamino)-4-(2,4,5-trifluorophenyl)butanoic acid is also used in the process of Abbreviated New Drug Application (ANDA) filing to FDA and toxicity study of respective drug formulation.