Total Nitrosamine Impurities

Limits of Nitrosamines
1

If our finished product includes two nitrosamine impurities, can we cover them with total organic impurities?

NIRA is required for both DS and DP? What about NDSRI risk assessments is it required only for DS or for both DS & DP.

2

Hi @rupesh.kelaskar, I will start with a read of the recent version of the EMA and FDA guidelines where a new approach was introduced when more than 1 nitrosamine is present.

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