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. 2023 Dec 12;14(5):100919. doi: 10.1016/j.jpha.2023.12.009

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© 2023 The Author(s)

This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

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Fig. 2 — Acceptable daily intake limits for selected nitrosamines impurities and nitrosamine drug substance-related impurities (NDSRI) in medicinal products as per regulatory authorities. NDMA: N-nitrosodimethylamine; U.S. FDA: United States food and drug administration; EMA: European medicines agency; WHO: World Health Organization; NDEA: N-nitrosodiethylamine; NNV: N-nitroso-varenicline; NMBA: N-nitroso-N-methyl-4-aminobutanoic acid; NDIPA: N-nitrosodiisopropylamine; NMPA: N-nitrosomethylphenylamine; NDBA: N-nitrosodibutylamine; EIPNA: N-nitrosoethylisopropylamine; MeNP: 1-methyl-4-nitrosopiperazine; NMOR: N-nitrosomorpholine.