Nitrosamine testing on stability samples?

[Naiffer_Host]

Please refer to the Joerg et al @schlinjo1975 publication in the post below. The stability studies performed and how it was mitigated is a model to follow in my opinion

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…