Lumateperone tosylate NDSRI impurity

N-nitrosamines Chemistry
1

Dear all,

As per my evaluation of Lumateperone tosylate drug substance.
There are 2 N-Nitrosoamine impurities structure are possible in API synthesis. (i.e N-Nitroso LMT1 and N-Nitroso Lumateperone). We confirmed both impurities and tested both impurity of API LMT1 Nitroso impurity content was found BDL in Lumateperone Tosylate (LT) API batches. N-Nitroso Lumateperone impurity (LMS) content was detected in Lumateperone Tosylate (LT) API batches. However, they are within the allowed Acceptable level (0.44 PPM).

Refere structure of N-Nitroso LMT1:

image.png.

Refere structure of N-Nitroso Lumateperone:

image.png

2

Please provide the structure of both impurities. We cant access the current structures