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Nitrosamine alerts: on 20 may 2022, EMA updated the Q&A documents on nitrosamine impurities

allerta-nitrosammine-15

20 May 2022 – EMA/409815/2020 Rev.9

EMA has updated the document “Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products” with:

  • Clarifications on what are the regulatory steps for dealing with scenario A cases
  • Update Q&A10 with new AIs (Nnitrosomethylphenidate, N-nitrosopiperidine, N-nitrosorasagilene, 7- Nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4]triazolo-[4,3- a]pyrazine, N-nitroso-1,2,3,6-tetrahydropyridine, Nnitrosonortriptyline, N-methyl-N-nitrosophenethylamine)
  • Guidance on use of Ames test

Please refer to the Questions & Answers document for complete information.

OUR CAPABILITIES

Thanks to the long-standing experience in nitrosamines analyses, Mérieux NutriSciences’ Pharmaceutical and R&D Divisions have developed and validated suitable high sensitive LC-MS/MS methods for a wide range of nitrosamines limit determination – and for specific NO-APIs as N-Nitroso Nortriptyline or N-nitroso rasagiline – in pharmaceutical products. In order to quickly respond to our customers, dedicated lines have been implemented to offer rapid and targeted analytical services for nitrosamine analysis.

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