Calculation for the Control of Multiple Nitrosamine Impurities

3-Alternateive ways of calculation for the control of Multiple nitrosamine impurities in the specification when results above 10% Of AI (Acceptable intake) is given below (as per EMA/409815/2020) -

Options for the control of multiple nitrosamine as per EMA/409815/2020 Rev.14 -

N- Nitrosamines present below 10% of their respective AI do not need to be factored into the calculation of limits for individual or total N-nitrosamine(s).

However, the overall principle of the Article 5(3) referral should still be considered, notably that “the presence of N-nitrosamines in human medicinal products shall be mitigated as much as possible.” Therefore, manufacturers are encouraged to improve their processes, even if they result in only very small amounts (<10% AI) of multiple nitrosamines, as processes and controls should be designed to prevent if possible or mitigate as much as possible the presence of N-nitrosamines in APIs and FPs.

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