What to do with Nitrite content reported by Excipients?

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I continue to get questions about why or what to do with the Nitrite content reported by excipients manufacturers. When it comes to NDSRIs this information is key for the risk assessment.

A post from our member @Yosukemino pointed out how is used to assess the formulation, you can also access the presentation that Dr. Urquhart’s on this

Define MDD to calculate limit

Dear all, thank you for the clarification. I guess the difference between Q3B and Q3D comes from the source of impurity, API, and the others. Impurities are defined as degradation products of API in ICH Q3B. And the impurity in API at 0.1% level is considered that in drug products at 0.1% level after formulation if no further degradations. Nitrosamines are treated as the same as other organic impurities in Q3B. The following is from Dr. Urquhart’s presentation in Lhasa Nitrosamine workshop. It …