ICH Q3 - To "Include OR Not to Include" impurities below reporting threshold

v9991

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#1
as per ICH Q3, reporting threshold defined based on primary criteria of "safety";
But at the same time, there is also a need for reporting total impurities.

scenario :- we have more than couple of peaks below reporting threshold. (and sum of those peaks is more than identification threshold! and potentially could increase on stability!)

My question is that , should we include them and report in total impurities?

my opinion is that, if method has an LOD < less than reporting threshold then they have to be included in total impurities. (irrespective of ICH criteria); if we do not exclude we will loose opportunity of trending and more importantly, the definition of total impurities is to include all which can be consistently quantified..

there is similar discussion on LInkedin, but it doesn't seem to conclude; beyond regulatory/compliance requirements!

Total impurities and reporting thresholds in HPLC
 
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v9991

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#2
probably i posted this query in incorrect sub-forum, can admin shift it to right/appropriate forum please.!
 
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