The TGA has published updated information for nitrosamine impurities in medicines consistent with recent EMA updated information. The changes include minor editorial amendments and inclusion of recently internationally determined AI limits for numerous nitrosamine impurities in medicines.
New nitrosamines
| Nitrosamine | CAS No abbreviations | Source* | AI limit (ng/day)** | CPCA Potency category | Date published (YYYY-MM-DD) |
|---|---|---|---|---|---|
| N-Nitroso-abacavir | Abacavir | 1500 | 5 | 2026/8/14 | |
| N-Nitroso-alprazolam EP Impurity H | Alprazolam | 1500 | 2026/8/14 | ||
| N-Nitroso-methylethylamine | 10595-95-6, NMEA | Amphotericin B | 26.5 | 2026/8/14 | |
| N-Nitroso-dabigatran etexilate amide | NNDH | Dabigatran etexilate | 1500 | 2026/8/14 | |
| N-Nitroso-diazepam Impurity D | 51145-18-7 | Diazepam | 100 | 2 | 2026/8/14 |
| N-Nitroso-desmethyl-cidoxepin | Doxepin | 18 | 1 | 2026/8/14 | |
| N-Nitroso-desmethyl-doxycycline | Doxycycline | 400 | 3 | 2026/8/14 | |
| N-Nitroso-desbutyldronedarone | Dronedarone | 1500 | 2026/8/14 | ||
| 6-Nitro-N-nitrosoadrenaline | Epinephrine / Adrenaline | 100 | 2 | 2026/8/14 | |
| N-Nitroso-meglumine | 62137-31-9 | Meglumine | 100 | 2 | 2026/8/14 |
| N-Nitroso-metamizole impurity E | Metamizole | 1500 | 4 | 2026/8/14 | |
| N-Nitroso-N-des(prop-2-enoyl)remibrutinib | LOU064-F8-NO | Remibrutinib | 100 | 2026/8/14 | |
| N-Nitroso-desmethyl-rifampicin | Rifampicin | 400 | 3 | 2026/8/14 | |
| N-Nitroso-desmethyl-ulipristal acetate | NDUPA | Ulipristal acetate | 100 | 2 | 2026/8/14 |
| N,Nā-Dimethylethylenedinitrosamine | 13256-12-7, NDMEA / NNDMA | 18 | 1 | 2026/8/14 |
Updated nitrosamines
| Nitrosamine | CAS No abbreviations | Source* | AI limit (ng/day)** | CPCA Potency category | Date published (YYYY-MM-DD) | Date/s updated (YYYY-MM-DD) |
|---|---|---|---|---|---|---|
| N-Nitroso-folic acid | 26360-21-4, NFA | Folic acid | NMI | 2023/8/24 | 2026-08-14; 2024-07-29 | |
| N-Nitroso-vancomycin | 155386-25-7 | Vancomycin | NMI | 2025/4/30 | 2026/8/14 | |
| 3-(Dimethylamino)propyl 2-[benzyl(nitroso)amino]benzoate | 3DPN | Benzydamine | 1500 | 2024/7/29 | 2026/8/14 | |
| N-Nitroso-labetalol | 2820170-74-7 | Labetalol | 1500 | 2023/8/24 | 2026/8/14 | |
| N-Nitroso-trimetazidine | 92432-50-3, NTMZ | Trimetazidine | 15000 | 2023/8/24 | 2026/8/14 | |
| N-Nitroso-paroxetine | 2361294-43-9 | Paroxetine | 1500 | 2023/1/5 | 2026/8/14 |