@Elif Thanks for your question. I suggest doing a search
Additionally, 2 posts that illustrate the use of these reported values of Nitrites in examples of risk assessments.
https://www.sciencedirect.com/science/article/pii/S0928098721003298?via%3Dihub
Back in October 2020, we saw an increased concern about the potential presence of NDMA in Metformin. @trust_user_a @trust_user_b @trust_user_c
âAs of October 2020, EMA and the national competent authorities are asking marketing authorization holders for metformin-containing medicines to test their medicines before releasing them onto the market,â said EMAâs Committee on Human Medicinal Products (CHMP) in an update to its post-authorization nitrosamine impurity testing proceduresâ
As a NitrosâŚ
I share the good example of nitrite calculation contained in excipients and others demonstrated by Dr. Urquhart in nitrosamine workshop last week.
[nitrite in excipient]
According to him, contamination risk is evaluated with 100% conversion at first. Next a conversion factor, whose detail is not included here, is considered and the calculated value is compared with (adjusted) ADI. This example may concern with API with secondary or tertiary amine, however if the amount of these amines is at âŚ
in the community using the tag âExcipientâ so you can see all the discussions that have been happening on the particularity of Excipients in Nitrosamines challenges.