Nitrosamine impurities in animal health APIs

Guidance, Documents, Resources
1

Is it required to evaluate nitrosamine impurities in animal health APIs?

Do we have any guideline for the same?

2

Hi

Although there is a (vague) note in the EMA guide: Nitrosamine impurities in human medicinal products, as much as I know there is no guideline so far requiring to establish a limit for NA in veterinary medicinal products. SeissMedic explicitly mentions there is no need for a risk assessment in veterinary drug products:

and also

Guidance document Formal requirements (PDF, 1 MB, 01.09.2025)

If anyone knows of other instructions/guidelines, I would be happy to learn as well.

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