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Nitrosamine Impurities Forum

The forum held in Amsterdam aimed to discuss the recent developments related to N-Nitrosamine impurities, the challenges faced by the pharmaceutical industry, and how to work towards possible solutions that may lead to a world with lower levels of nitrosamines.

The first day was hosted by the doyen of nitrosamines impurities Dr. Andrew Teasdale and focused on the latest trends and challenges in N-Nitrosamines, safety assessments, regulatory frameworks including ICH-M7 and risk assessment models with various case studies.

Adding more to the knowledge-base of participants, the second day focused on imparting a deep understanding of various aspects of nitrosamines impurities backed by multiple speaker sessions and panel discussions from distinguished industry experts.

Lhasa Limited Principal Scientist, Dr. Michael Burns gave a talk, ‘Purge Factors as part of M7 Assessment of Mutagenic Impurity Risk’, on the potential impact on demonstrating nitrosamine control using Mirabilis. He also co-presented a paper, ‘The Landscape of Potential Small and Drug Substance Related Nitrosamines in Pharmaceuticals‘ with Joerg Schlingemann from Merck.