Any knowledge of the limit that manufactures have been working against?
Prof @ymleefn any insights?
EMA CMDh requested to NcWP for N-nitroso tamsulosin AI limit derivation in its April 2023 meeting. So its AI is in progress work…
In Australia, the TGA has set a limit of 18ng per day
Health Canada published a limit of 18ng per day.
Additionally ANVISA also include Nitroso tamsulosine in its recently updated (Version 3) guidance on Control of Nitrosoamine impurities with same AI i.e 18 ng/day as like health Canada and TGA