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Virtual summit: Mérieux NutriSciences talks about Nitrosamine impurities

Mérieux NutriSciences invites you to follow our experts during their speech on Nitrosamine impurities during the 3rd Annual genotoxic impurities in pharmaceuticals virtual summit.

Mérieux NutriSciences
talks about Nitrosamine impurities

Friday, 10 March 2023 – 1:30-2:30 p.m. (CET)

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Nitrosamines are chemical compounds classified as probable human carcinogens. The first alert from regulatory authorities was in mid-2018 when nitrosamine impurities -including N-nitrosodimethylamine (NDMA) were detected in sartans-based pharmaceutical products. This triggered a series of global-scale investigations that led to the revelation of the presence of other low molecular weight N-nitrosamines (e.g., NDEA, NDIPA, NDELA, NMOR) in many APIs and finished products, sometimes forcing companies to recall products.

Nitrosamine impurities investigation, an alert that will continue in the future
EMA has recently underlined that MAHs should note the risk of formation of (complex) nitrosamine impurities from active substances (or their related impurities) containing a vulnerable amine during finished product formulation and/or storage due to the presence of traces of nitrites (refer to official Q&A document). This is a new big emerging issue that is impacting several drug products on the market, requiring to review the original step 1 risk evaluations in light of this new information and to perform step 2 confirmatory testing as appropriate.

What about our speech?
Our scientific experts, Sergio Fasan and Emiliano De Dominicis, will deliver the speech “Enhancing nitrosamines analysis: a focus on complex nitrosamines (NDSRIs or NO-APIs)”:

  • Regulatory framework updates
  • NDSRIs or NO-APIs: emerging issues
  • Nitrosamines formation risk factors
  • Mérieux NutriSciences global service: analytical challenges for QC & skip/waiving approaches
  • Case studies from Mérieux NutriSciences Pharma Nitrosamines Labs

Our outstanding expertise
With more than 15 years’ experience on nitrosamine analysis, Mérieux NutriSciences’ Pharmaceutical and R&D Divisions have quickly established a GMP task force to implement and validate targeted research methods.
Thanks to the long-standing experience in the chemical industries, our experts have been developing various strategies and approaches for the determination of simple and complex nitrosamines in pharmaceutical products.

The Speakers

SERGIO FASAN
Business Director – Pharma, Healthcare & Cosmetics
Sergio Fasan is currently Business Director of the Pharma, Healthcare and Cosmetics Business Unit at Mérieux NutriSciences Italy. He started the collaboration with Chelab twenty-two years ago covering different roles during the time, starting as Laboratory Manager, and later as Quality Control Manager of the GMP Facility, Director of the GLP Facility and Business Unit Manager of the GxP Division at Mérieux NutriSciences Italy.

EMILIANO DE DOMINICIS
Chemistry Research Director
Emiliano De Dominicis is a researcher with over twenty years of experience in food and pharmaceutical safety, following both private and academic sectors, and he is now Director of Chemical Research – Project Manager at Mérieux NutriSciences. With a Research and Development in Analytical Chemistry dedicated team, Emiliano is responsible for Mérieux NutriSciences Global Research Projects and Scientific Center. Moreover, Emiliano De Dominicis actively participates in funded scientific projects (regional, national and European), scientific congresses as speaker, and writes articles published in specialized scientific journals.