How to Define Limit For Newly Identified Nitrosamine Impurity? 

very nice explanation

Very nicely articulated huge lot of information in one presentation! Kudos to you!

Dear sir, Kindly also prepare the video about DS impurity (degradent impurity)which is above the qualifications limit and suggest the calculation of how to prepare justification in sec. 3.2.S.3.2 on base repeat dose tox. Study NOAEL. Thank you for above video, it's helpfull

You mentioned that EWGs reduce toxicity, and you also said that hydroxy groups reduce toxicity because of that. But hydroxy groups are EDGs, so what is it? Do EWGs reduce toxicity or EDGs?

How 18ng/day come into knowledge???

Thanks for knowledge sharing sir

Good presentation