Merck has discovered that nitrosamine NTTP in its blockbuster diabetes medications arose mostly during storage, as well as during manufacturing and believes it can resolve the problem by the end of the year

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Nitroso-Sitagliptin Who/Where/Limit?

A community member brought it to my attention and ask to share it. EMA and Health Canada have issued an update on viz Nitroso-Sitagliptin (7-Nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro [1,2,4] triazolo- [4,3- a] pyrazine). The impurities have been found in both API and finished dosage form (DP) EMA has defined a maximum exposure limit of 37ng/day The nitroso-impurity appears in both as a process impurity in the API and in the drug product, which seems to increase over time during storage A…