Dear Yosuke, many thanks for your information.
Do you have identify the corrections which have been done in this update?
kind regards
Christos
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Thank you for asking, Cristos. I compared both Excel. Smiles and structure of N-nitroso-tizanidine Impurity 3 differed from each other.
In addition, the K Line(First publication date) was described as the “publication date” in the old version. Due to this change, the K line (first edition publication date) of 21 nitrosamines has been changed from the previous version.
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thanks a lot for your time Yosuke, it is much appreciated!!
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EMA Appendix 1 was updated on 5 February 2025. Twelve nitrosamines are added to the list.
| Nitrosamines | CPCA Cat. | AI (ng/day) |
|---|---|---|
| 2-(N-nitrosomethylamino)-N-[6-(trifluoromethoxy)-1,3-benzothiazol-2-yl]acetamide | 2 | 100 |
| N-nitroso-dalbavancin | 4 | 1500 |
| N-nitroso-dasatinib | 5 | 1500 |
| N-deshydroxyethyl-N-nitroso dasatinib | 3 | 400 |
| N-nitroso-desmethyl-cabergoline | 1 | 18 |
| N-nitroso-desmethyl-lercanidipine | 2 | 100 |
| N-nitroso-desmethyl-lercanidipine impurity D | 2 | 100 |
| N-nitroso-N-desmethyl-mianserin | 3 | 400 |
| N-nitroso-nirogacestat | 1 | 18 |
| N-nitroso-norfloxacin | - | NMI* |
| N-nitroso-sarcosine | 4 | 1500 |
| N-nitroso-vancomycin | 4 | 1500 |
*Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of n-nitroso-ciprofloxacin as point of departure.
N-nitroso-ciprofloxacin
N-nitroso-norfloxacin
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TD50 of n-nitroso-ciprofloxacin? 
I am scratching my head right now. Do someone really did a Carc. test for N-Nitroso Ciprofloxacin? Good thing is that similar structures (some piperidine like ones perhaps too?) would be able to read across from that TD50?
I checked, the argumentation line in N-Nitroso Ciprofloxacin and still says -tive in In-vivo mutagenicity test.
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I think this is just a typo. 