We offer preparation of complex risk assessment reports for nitrosamines contamination as per current regulatory requirements . In case of lack of manufacturer's declaration regarding trace amounts of nitrites in excipients we are still able to analytically verify the possibility of nitrosamines formation for every particular formulation (as part of Step 1 risk analysis) . Thereby lack of declaration, or declaration stating the trace amounts of nitrites are possible to find in the excipient, do not have to lead to expensive Step 2 analyses (Confirmatory testing).
It has to be remembered that as per current regulatory requirements the range of nitrosamines in the drug product is not limited to those listed in the guideline (NDEA, NDMA, EIPNA, DIPNA and others) but the analyses should cover other nitrosamines including nitroso API and nitrosamines formed from known impurities. By employing our approach we can justify lack of risk as part of Step 1, which significantly reduces the cost of analyses required as part of Step 2 analyses (testing for low molecular weight nitrosamines and API/Impurities derivatives).
The cost of a single risk analysis using the author's approach giving the opportunity to avoid the analyses required by Step 2 is PLN 12,000 net (prices can be negotiated in case of a larger number of reports).
