A fantastic reflection on the chemistry of Nitrosamines Impurities. Published by Jires et al. “N-Nitrosation in the absence of nitrosating agents in pharmaceuticals?”
Access here: N-Nitrosation in the absence of nitrosating agents in pharmaceuticals? - ScienceDirect
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FDA mentions the addition of bases such as Na2CO3 is effective to prevent nitrosation in the mitigation approach. It’s reasonable. The excerpt is as follows;
A second possible approach is based upon the fact that the formation of nitrosamines typically occurs under acidic conditions, whereas, in a neutral or basic environment, the kinetics of these reactions are significantly reduced. Thus, formulation designs that incorporate excipients such as sodium carbonate that modify the micro-environment to neutral or basic pH, should in principle inhibit the formation of NDSRIs. Each manufacturer should determine the potential benefit from and demonstrate the suitability of any reformulation approach.
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