We offer the preparation of a comprehensive risk analysis report for nitrosamines in accordance with the current requirements of the registration authorities. In the absence of a declaration of the absence of trace amounts of nitrites in the excipients, we are able to analytically verify the possibility of nitrosamine formation for each formulation (Step 1 verification). Thus, the absence of a declaration, or a declaration with an inference of the presence of nitrites, does not necessarily result in the tests required for Step 2 (Confirmatory testing).

Please note that currently, tests under Step 2 do not cover only nitroso compounds listed in the guideline (NDEA, NDMA, EIPNA, DIPNA and others), but should also include tests conducted for the presence of nitroso-derivative APIs and nitroso-derivatives of known contaminants. Our approach allows us to defend the lack of need to carry out the above-mentioned analyzes as part of Step 2 and end the process at the stage of the report with a conclusion about the lack of risk.

The cost of a single risk analysis using the author's approach giving the possibility of avoiding the analyses required by Step 2 is 12 000 PLN net (prices may be negotiated in the case of a larger number of reports).

Nitrosamines background