New NDSRIs
| Name | Source | CPCA | AI(ng/day) | Note |
|---|---|---|---|---|
| N-nitroso-2,4-thiazole amine | Nirmatrelvir/ Ritanovir | 1 | 18 | CPCA-derived AI as substance tested positive in in vivo mutagenicity study |
| N-nitroso-acebutolol | Acebutolol | 4 | 1500 | |
| N-nitroso-buspirone Impurity 1 | Buspirone | 3 | 400 | |
| N-nitroso-desmethyl-dimetindene | Dimetindene | 1 | 18 | |
| N-nitroso-desmethyl-rivastigmine | Rivastigmine | 2 | 100 | |
| N-nitroso-iminodibenzyl | Melipramin | 78000 | Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NDPh as point of departure. | |
| N-nitroso-maprotiline | Maprotiline | 1 | 18 | |
| N-nitroso-propafenon | Propafenon | 2 | 100 | |
| N-nitroso-valsartan cyano-desvalerylmethylester | Valsartan | 2 | 100 | |
| N-nitroso-vanzacaftor | Vanzacaftor | 4 | 1500 | |
| N-nitroso vildagliptin amide impurity | Vildagliptin | 5 | 1500 |
Updated NDSRIs
| Name | Source | CPCA | AI(ng/day) | Note |
|---|---|---|---|---|
| N-nitroso-ciprofloxacin | Ciprofloxacin | NMI | Substance tested negative in in vivo mutagenicity study. Can be controlled according to ICH Q3B. | |
| N-nitroso-diclofenac | Diclofenac | 78000 | Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NDPh as point of departure. | |
| N-nitroso-nortriptyline | Amitriptyline, Nortryptyline | 1 | 18 | CPCA derived AI as substance tested positive in in vivo mutagenicity study |
| N-nitroso-sertraline | Sertraline | 2 | 100 | CPCA-derived AI as substance tested positive in in vivo mutagenicity study |
N-nitroso-ciprofloxacin: 1500 => NMI
N-nitroso-diclofenac: 1500 => 78000
N-nitroso-nortriptyline: 8 => 18
N-nitroso-sertraline: 1500 => 100
The AI of some Category 5 compounds may be changed to 78000.