The effect of nitrite and nitrate presence in raw materials on nitrosamine risk

[Naiffer_Host]

@Elif Thanks for your question. I suggest doing a search in the community using the tag ‘Excipient’ so you can see all the discussions that have been happening on the particularity of Excipients in Nitrosamines challenges.

Additionally, 2 posts that illustrate the use of these reported values of Nitrites in examples of risk assessments.

NDMA analytics in metformin products: Comparison of methods and pitfalls

How to avoid NDMA in Metformin? (In press)

Back in October 2020, we saw an increased concern about the potential presence of NDMA in Metformin. @trust_user_a @trust_level_1 @trust_user_c “As 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,” said EMA’s Committee on Human Medicinal Products (CHMP) in an update to its post-authorization nitrosamine impurity testing procedures” As a Nitro…

Lactose, Nitrosamine Risk?

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 …