TGA updated Established acceptable intake for nitrosamines in medicines on 29 January 2026

https://www.tga.gov.au/safety/safety-monitoring-and-information/nitrosamine-impurities-medicines/established-acceptable-intake-nitrosamines-medicines

Nitrosamines with updated AIs;
N -Nitroso-berotralstat: 1500ng/day
N -Nitroso-bumetanide: 1500ng/day
N -Nitroso-N-desmethyl-diphenhydramine: 100ng/day
N -Nitroso-N-methyl-valaciclovir: 1500ng/day
N -Nitroso-perindopril: NMI
N -Nitroso-pseudoephedrine: 1500ng/day
N -Nitroso-ramipril: NMI

New Nitrosamines:
N -Methyl-N-nitrosoanthranilate: 100ng/day
N -Nitroso-4-phenylpiperazine: 400ng/day
N -Nitroso-cytisine: 400ng/day
N -Nitroso-desbutyl-lumefantrine: 1500ng/day
N -Nitroso-desmethyl-mifepristone: 100ng/day
N -Nitroso-desmethyl-tapentadol: 18ng/day
N -Nitroso-selumetinib: 78000ng/day
N -Nitroso-ephedrine: 1500ng/day
N -Nitroso-relebactam: 400ng/day
N- Nitroso-olanzapine: 1500ng/day
N- Nitroso-elagolix: 1500ng/day
2-(2-(4-Nitrosopiperazin-1-yl) ethoxy)ethan-1-ol: 1500ng/day

established-acceptable-intake-for-nitrosamines-medicines_29 January 2026.pdf (189.9 KB)

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