Appendix 1: Established acceptable intake (AI) limits for N -nitrosamine impurities
17 Additional nitrosamines and one nitrosamine with revised AI are as follows;
| Nitrosamine | DP | CPCA | AI(ng/day) |
|---|---|---|---|
| N-nitroso-desmethyl-almotriptan | Almotriptan | 1 | 18 |
| N-nitroso-N-desethyl-amiodarone | Amiodarone | 1 | 18 |
| N-nitroso-N-desmethyl-cabergoline | Cabergoline | 1 | 18 |
| N-nitroso-N-desmethyl-diltiazem | Diltiazem | 1 | 18 |
| N-nitroso-N-despropyl-ropinirole | Ropinirole | 1 | 18 |
| N-((2- isopropylthiazol-4-yl) methyl)-N-methylnitrous amide (NNTA) | Cobicistat | 1 | 18 |
| N-nitroso-brinzolamide | Brinzolamide | 2 | 100 |
| N-nitroso-carvedilol | Carvedilol | 3 | 400 |
| N-nitroso-safinamide | Safinamide | 3 | 400 |
| N-nitroso-N-desmethyl-methadone | Methadone | 3 | 400 |
| N-nitroso-dalbavancin | Dalbavancin | 4 | 1500 |
| N-nitroso-norfloxacin | Norfloxacin | 4 | 1500 |
| N-nitroso-vancomycin | Vancomycin | 4 | 1500 |
| (2S,4R)-N-(6-bromopyridin-2-yl)-4-fluoro-1-nitrosopyrrolidine-2-carboxamide | Danicopan | 4 | 1500 |
| N-nitroso-vanzacaftor ^ | Vanzacaftor | 4 | 1500 |
| N-nitroso-acarbose | Acarbose | 5 | 1500 |
| N-nitroso-nadolol | Nadolol | 5 | 1500 |
| N-nitroso-N-desmethyl-doxylamine | Doxylamine | - | 100 (revised from 18) |
^ CPCA category was established using a correction to account for the 5-carbon chain feature length