Exploration and Detection of Nitrosamine Impurity Nitroso-STG-19 in Sitagliptin Tablet and API as well as Nitrites in Excipients by LC-MS/MS Methods

The Food and Drug Administration (FDA) recently reported a new nitrosamine impurity in sitagliptin that was named nitroso-STG-19 (NTTP), whose acceptable intake limit was extremely low at 37 ng per day. In addition, NTTP was found to be a degradation impurity in sitagliptin tablets, which was formed by the reaction of 3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-