The European Pharmacopoeia (Ph. Eur.) published its new general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36) for a 3-month public consultation in Pharmeuropa 32.2. The closing date for public comments was 30 June 2020.
Given the exceptional circumstances due to the COVID-19 pandemic, we would like to remind stakeholders who were not able to provide comments before the end of June to contact their respective national pharmacopoeia authority (NPA) or the EDQM as soon as possible so as to announce their intent to comment (see also the news from 15 April 2020). The general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36) will remain available in the Pharmeuropa archives issue 32.2 and comments must be sent no later than 31 August 2020. Comments made after this date will be too late for consideration.
So don’t miss out on the opportunity to submit your comments on the new general chapter and to actively participate in the elaboration of an important public quality standard for regulators and industry (How to comment).
The general chapter proposes three procedures relying on more or less sophisticated instruments (from GC-MS to LC-MS/MS and GC-MS/MS) and that, in total, cover seven N-nitrosamine impurities: N-nitroso-dimethylamine (NDMA), N-nitroso-diethylamine (NDEA), N-nitroso-dibutylamine (NDBA), N-nitroso-N-methyl-4-aminobutyric acid (NMBA), N-nitroso-diisopropylamine (NDiPA), N-nitroso-ethyl-isopropylamine (NEiPA) and N-nitroso-dipropylamine (NDPA). The three procedures have been validated as limit tests with a target concentration of 30 ppb, for given active substances. It was considered important to include a varied set of procedures using different instruments, thus covering the needs of many quality control laboratories in Europe and beyond.
In addition, given the global use of the medicines which have been found to contain nitrosamine impurities, the European Pharmacopoeia and the United States Pharmacopeia will work on convergence and ensure that their public quality standards are harmonised.