Sitagliptin NTTP nitrosamine impurity maximum active intake level 37ng to 246.7 ng/per day

Thank you for responding, @Diego_HM. Though the pharmaceutical companies evaluated the risk of nitrosamine contamination from several points, the limit has stayed conservatism, 37 ng/day. If CPCA is available, they may provide different control strategies…

As far as I know, there is no document translated into English. I translated it with AI translation, but I am not sure of the correctness.

Risk assessment of sitagliptin english.pdf (7.4 MB)

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