We are delighted to be taking part in an online seminar and panel discussion with ThermoFisher Scientific on 29th October, 12 pm (EDT)/4 pm (GMT)
Nitrosamine Drug Substance related impurities (NDSRIs) remain a topic of significant concern to the pharmaceutical industry with multiple batch recalls in 2022+ across different drug classes including beta blockers and ACE inhibitors to name but a few. With secondary amine containing APIs having the potential for nitrosation in the presence of nitrite and acidic conditions there is an inherent risk of their formation during pharmaceutical manufacture and storage. Such NDSRIs pose a significant challenge due to the lack of specific carcinogenicity. Without this it is challenging to determine when, where or indeed if, there is a need to develop an associated analytical method. While the advent of the Carcinogenicity Potency Categorization Assessment (CPCA) has provided a systematic way to define an AI the challenges of analyzing NDSRIs at part per billion levels remains extremely challenging.
In this part online seminar part panel discussion, we will present and discuss nitrite in excipients, nitrite and NDSRI analysis methods and challenges, NDSRI risk assessment and a comprehensive and industry accessible NDSRI database hosted by Lhasa Limited. It will examine the challenge of NDSRI analysis include matrix effects and the risk of false positive results arising during sample preparation. Lhasa Senior Global alliances manager Grace Kocks will be speaking on the panel.