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_user_b @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 Nitrosamine knowledge community, our center of attention lies in the understanding of how it happened and how to prevent it. I applaud the efforts of so many scientists in the community that pushes their organizations to share openly the lessons learned and the results of their research.

Joerg (@schlinjo1975) et all. just published ‘Avoiding N-Nitrosodimethylamine Formation in Metformin Pharmaceuticals by Limiting Dimethylamine and Nitrite’… They have performed an extensive analysis of NDMA concentrations along the API manufacturing process, and data mining exercise based on NDMA analysis of more than 2000 historical batches.

Please share you comments & questions here with Joerg.

Open access: Avoiding N-nitrosodimethylamine formation in metformin pharmaceuticals by limiting dimethylamine and nitrite - ScienceDirect


If you are looking for a ‘best-practice’ investigation framework for your product, please read carefully the synopsis of the work that Joerg and the team completed as part of their investigation for the Metformin product.

NDMA formation throughout the Metformin process steps, across batches, suppliers, and sites.


Hi Naiffer; It is great to be a part of the USP and the nitrosamines exchange. I appreciate your hosting the group as well. I am looking for a way to assay my prescription medications for NDMA from an independent laboratory company. I did send a lengthy email to the USP/NF and would like to send you the same email for your reflection. I spell out all the information and my connection to the NDMA problem. Is anyone working on the ban of this product? And I was told to send my concerns to the U. S. FDA and also to report the issue with NDMA to Medwatch to report the problems with my medication there. The problem is the cart is before the horse so to speak and I need to confirm there is NDMA in my medications first before I report anything to the FDA or to Medwatch.
Everything is explained in my email to USP/NF.
Thank you again Naiffer and I look forward to your correspondence.