The effect of nitrite and nitrate presence in raw materials on nitrosamine risk

I perfectly agree with @Naiffer_Host.

The following discussion may help you understand the importance of nitrites in excipients, @prealbhatt.

The former is the topic for performing risk assessment by calculating the amounts of nitrites.
We should consider risk factors such as the maximum daily dose of the drug (API), the molecular weight of nitrosamines, acceptable intake of nitrosamines, the amounts of excipients used, and nitrite amounts in other excipients. It’s the calculation of the model case, but it’s the same at confirmatory testing.

The latter is the topic related to low nitrites excipient. Some companies sell excipients with low nitrites excipients with measured values. This information is helpful for pharmaceutical companies.

In conclusion, we cannot say less than one ppm of nitrites in excipients is always enough, but the information is helpful.