Control of NDSRIs impurity at Drug Substance (API) specification

[Naiffer_Host]

This posts can be very helpful

Nitrosamine in DS and DP specifications

Dears, I want to ask if the detected nitrosamine is consistently below 30% of AI, should it be added the COA of the DS or DP. In other words, how the “skipping” should be reflected in the regulatory documents. Also, what is the regulatory criteria for the term “consistently”, is there certain number of batches to be tested? Regards, Alaa

Testing of APIs for NDSRI

I am searching reference document for implementation of skip testing for the NDSRI, if results of NDSRI is above 10% of specification limit and below 30% of specification limit. If someone can help to provide reference / strategy for the same, it will be great help.