Recent update on Nitrosamine Impurities by EP and US Pharmacopoeia

 

The European Pharmacopoeia (Ph. Eur.) published its new general chapter on the analysis of N-nitrosamine impurities inactive substances (2.4.36) for a 3-month public consultation in Pharmeuropa 32.2. The closing date for public comments was 30th June 2020. Given the exceptional circumstances due to the COVID-19 pandemic, would like to remind stakeholders to provide comments before the end of June to contact their respective national pharmacopeia Authority (NPA) or the EDQM as soon as possible so as to announce their intent to comment. The general chapter on the analysis of N-nitrosamine impurities inactive substances (2.4.36) will remain available in the Pharmeuropa archives issue 32.2 and comments to be sent no later than 31^st August 2020, comments after this date will be too late for consideration.

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