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

[Yosukemino]

Hi, @Elif. I think this post is also helpful for you to understand the amounts of nitrites in excipients and their contribution to the drug product.

A Nitrite Excipient Database - Risk Assessment

If you haven’t, I encourage you to read the recent publication " A Nitrite Excipient Database: A Useful Tool to Support N- Nitrosamine Risk Assessments for Drug Products" by Boetzel et al. A fantastic update on the data-sharing consortium, maintained by Lhasa Limited. The goal of the initiative is to provide a common framework to contextualize and estimate the risk posed by the presence of nitrites to contribute to the formation of nitrosamines in drug products. Key takes aways: Average nitr…