Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide impurity formation and its inhibition in bumetanide tablets -Pub

[Naiffer_Host]

A the recent CRGC/FDA meeting, Dr. Diaa Shakleya presented a study on the screening and effectiveness of potential scavengers to prevent Nitroso-API formation.

This week a team from FDA published “Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide impurity formation and its inhibition in bumetanide tablets”

https://jpharmsci.org/article/S0022-3549(23)00244-7/pdf

Meeting details:

Mitagation Strategy for NDSRIs (FDA & CRCG) Workshop

Next June 15th, FDA and Center of Research on Complex Generics (CRCG) is organizing a hybrid workshop on Mitigation strategies for Nitrosamine Drug Substance Ralted Impurities: Quality and Bioequivelance considerations for Generic Products The purpose of this workshop is to discuss the risks of forming NDSRIs in certain drug products, strategies to mitigate these risks, and considerations in assessing the safety risks of NDSRIs. The workshop will also discuss approaches to prevent or mitigate t…

Dr. Shakleya Presentation at CRCG/FDA meeting:

1-6_Session1_DiaaShakleya.pdf