Last 17-July-2024 the European Medicine Agency published the draft of “Guideline on the Development and Manufacture of Oligonucleotides”, By the way, open for comments until 31-Jan-2025
Nitrosamine did not scape from being mentioned in the guideline.
Oligonucleotides are included in the scope of ICH Q3D ‘Guideline for Elemental Impurities’ (Reflection 834 paper EMA/CVMP/QWP/153641/2018 for veterinary products), thus the requirements laid down in this guideline are applicable for medicinal products containing oligonucleotides as active substances. Also the risk considerations and requirements for nitrosamine impurities are applicable to oligonucleotide active substances that are used in finished products for human use