LOD

[priyacapila]

Is there anything from either USP or FDA that supports deleting peaks that are below LOD. We know that it makes sense to do so because impurities at that level tend to “come and go”, but some methods have such a high LOD that one can end up deleting a significant level of impurities, which could be a red flag. Any thoughts?

[martsims]

There is guidance in the ICH Q3 guidelines around reporting of impurity levels