🇧🇷 Guideline for the control of Nitrosamines Rev. 4

Guidance, Documents, Resources
23

NMPA
EMA Appendix 1 RAIL until 20 November 2023: 34.3 ng/day
EMA Appendix 1 RAIL after 20 November 2023: 100 ng/day

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24

Do anyone have the excel released by FDA & USP to calculate CAPA score for NDSRI.

Thanks
Vivek

26

Dear all, you will find below in case useful :wink:

  • detail for new and updated compounds (now in new annex 1 instead in the doc)
  • attaching the guideline roughly highlighted for changes vs version 3

Regards form Germany ¡!
Estefy

New x18

Nitrosaminaoctaidrociclopentapirrol (Y101), CAS 62-75-9  AI 1700 ng/day 

Nitrosaminanortriptilina (NNORT), CAS 55855-42-0  AI 8 ng/day

Pramipexolnitrosamina  AI 400 ng/day

Diclofenaconitrosamina, CAS 66505-80-4  AI 1500 ng/day

Nebivololnitrosamina, CAS 1391051-68-5  AI 1500 ng/day

Bisoprololnitrosamina, CAS 2820170-76-9  AI 1500 ng/day

Ciprofloxacinonitrosamina, CAS 864443-44-7  AI 1500 ng/day

Moxifloxacinonitrosamina  AI 1500 ng/day

Atenololnitrosamina, CAS 134720-04-0  AI 1500 ng/day

Betaistinanitrosamina, Cas 32635-81-7  AI 18 ng/day

Vildagliptinanitrosamina  AI 1500 ng/day

Desloratadinanitrosamina, CAS 1246819-22-6  400 ng/day

Fenilefrinanitrosamina, Cas 78658-64-7  100 ng/day

Buproprionanitrosamina, CAS 2763780-10-3  AI 1500 ng/day

Bumetanidanitrosamina, CAS 2490432-02-3  AI 1500 ng/day

Hidroclorotiazidanitrosamina, CAS 63779-86-2  NMI

Azitromicinanitrosamina  NMI

Desmetilazitromicinanitrosamina  NMI

Updated x10

Nitrosaminaparoxetina, new CAS 2361294-43-9  AI 1300 ng/day

ácido mefenamiconitrosamina, new CAS 2114-63-8  AI 78.000 ng/day

Etilisopropilnitrosamina, CAS 16339-04-1  AI from 26.5 to 400 ng/day

di-isopropilnitrosamina, CAS 601-77-4  AI from 26.5 to 1500 ng/day

Carboxipropilmetilnitrosamina, CAS 61445-55-4  AI from 96.0 to 1500 ng/day

Metilnitrosopiperazina, CAS 16339-07-4  AI from 26.5 to 400 ng/day

Nitrosovareniclina, new CAS 2755871-02-2-  AI from 37.0 to 400 ng/day

Trifluormetiltetraidrotriazolnitrosopirazina, CAS 2892260-32-9  AI from 37 to 100 ng/day

Nitrosaminarasagilina, CAS 2470278-90-9  AI from 18 ng/day to 100 ng/day

Dabigatrananitrosamina, CAS 2892260-29-4  AI from 18 to 1500 ng/day

Deleted x1 → nitrosaminatansulosina 18 ng/day

Of note: “nitrosaminatetraidropiridina (NTHP), CAS 55556-92-8  AI 37 ng/day” is repeated in the list of Annex I.

Guia_50-2021_versão 4_31 Jul 2024_changes highlithed EDS.pdf (1.5 MB)

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27

@Naiffer_Host What is the full form of IFA’s on page number 11 of guideline.

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28

Insumos Farmacêuticos Ativos (IFA’s): Active Pharmaceutical Ingredients

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