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European Biopharmaceutical Review

Genotoxic Impurities in Drug Products: Review of Nitrosamine Assays

Nitrosamines are organic compounds that we are exposed to in our everyday lives. They are common in water and foods, including cured and grilled meats, dairy products, and vegetables.

Nitrosamines are classified by the ICH M7(R1) Guideline as class one impurities, ‘known mutagenic carcinogens,’ based on both rodent carcinogenicity and mutagenicity data (1). They are categorised by the International Agency for Cancer Research as 2A – probable carcinogens based on data on a number of species studied (2).

Nitrosamines became a news focus for medicine authorities in mid-2018, when a Chinese drug substance (DS) manufacturer detected the presence of N-nitrosodimathylamine (NDMA), in batches of valsartan (3). Meanwhile, different nitrosamines were detected in almost every drug product which contains a ‘sartan’ derivate as a DS.

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Elodie Barrau is the Site Manager of Eurofins Amatsi Analytics in Toulouse area, France, with focus in chemistry, manufacturing and control, scientific support (GLP and GMP) for international preclinical, pharma, clinical development and/or registration, and implementation of analytical analysis. Elodie has a degree in Agronomist Engineering specialising in Phytochemistry Drug Development.

Emmanuel Desmartin is Mass Spec and Bioanalysis Lab Manager at Eurofins Amatsi Analytics, with 15 years of experience in bioanalysis; holding different positions in CROs as study director in development and validation of LC-MS methods, management of mass spec lab, and technical support.

Valentina Paschetta is Method Set Up and Validation Lab Manager at Eurofins Biolab, in Milan, Italy. Valentina began working as synthetic chemist in a pharmaceutical R&D department, before moving to analytical chemistry where she gained 15 years of experience in methods development and validation.

Davide Tartaglione is Senior Consultant at Eurofins Biolab. After graduating with a degree in biology, he gained experience in the regulatory field working in a consulting firm and contract manufacturing organisations. Davide is now part of Eurofins Consulting team with focus in the pharmaceutical area.

Mònica Coll Furest is Head of the Chemistry Laboratory at Eurofins BioPharma Product Testing Spain, in Barcelona. With a degree in Chemistry from Ramon Llull University, Spain, along with a Chemical Engineering and an Environmental Sciences degree from Institut Químic de Sarría, Spain. Monica has been in charge of the chemistry lab for more than 20 years, working in the pharma sector and also working in bioanalysis for 15 years.

Ana Novak, PhD, is Analytical Method Establishment Technician at Eurofins BioPharma Product Testing Spain, with a degree in Pharmacy from the University of Ljubljana, Slovenia, a doctorate in Pharmacy from the University of Barcelona, Spain, and several years of experience in method development and validation for the pharmaceutical sector.
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Elodie Barrau
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Emmanuel Desmartin
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Valentina Paschetta
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Davide Tartaglione
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Mònica Coll Furest
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Ana Novak
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