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How to predict for the formation of NDSRIs

Nitrosamine Drug Substance-Related Impurities (NDSRIs) have become a major concern in the pharmaceutical industry due to their potential to pose serious health risks to patients. Understanding how to predict and manage the formation of NDSRIs is vital to ensure the highest quality and safety standards are met in drug development and manufacturing processes.

In this webinar, we assembled a distinguished panel of experts who specialize in the fields of pharmaceutical process chemistry and quality control. Their vast knowledge and experience guided us through the complexities of predicting the formation of NDSRIs and the practical approaches to mitigate these risks effectively.

Dr Leonardo Allain, Distinguished Scientist at Merck discussed excipient nitrite risk assessment, mitigation strategies Merck have considered and how using data can support a nitrosamine assessment.

Dr Giorgio Blom, Senior Trace Analysis Lead at AstraZeneca presented on Nitrite test methods, their associated challenges and ongoing comparative testing.

Dr James McManus, Senior Scientist at Lhasa Limited presented on Lhasa’s most recent work surrounding nitrosamine impurities, including nitrosamine formation risk technology within Mirabilis and nitrosating pathway prediction in Zeneth.