Considerations for high-risk unit operations


Do any experts share some ideas/ experiences regarding NDSRI formation during high-risk unit operations (e.g., fluid bed drying, wet granulation)?

Also, could anyone share the full text of literature down below?
Thank you!
Moser, J.; etal, N-Nitrosamine formation in pharmaceutical solid drug products: experimental observations., J. Pharma. Sci. 2023, 112, 1255.

Hello. There is a lot of literature in the food sector about nitrosamine formation during drying operations. Air quality can be critical here, as any direct heating of the air can introduce NOx which can react with secondary amines.


NOx should not be overseen… check the recent presentation by Dr. Grahek at the CRCG meeting on “Determination of nitrite in pharmaceutical excipients; air as a source for higher nitrite levels.”