Higher limits allowed by FDA for Nitroso-sitagliptin

[Naiffer_Host]

I suggest looking into this two publications:

Dr. Schlingemann @schlinjo1975 reported at a recent workshop in Amsterdam the results of NDMA formation dynamic in 5-year-old batches of metformin tablets linked to water content, i.e. Low water content has caused increased NDMA formation.

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 Nitros…

Also reports of NDMA in-situ formation in DCM, which suggest the use of nitrite scavenger in sample preparations for NDMA testing

NDMA Analytics in Metformin -Methods and Pitfalls?

Recently @TonyBristow shared via LinkedIn this great article that highlights not just the challenges of method development but pitfalls when it comes to nitrosamine confirmatory testing. Several contributors in the publications are members of our community @giorgio @Elodie @MarkWH @schlinjo1975 Authors and community members will welcome your comments and questions. The article is currently in Pre-proof, but Open-access [image] #Metformin