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- Posts: 95
- Joined: Fri Nov 30, 2012 5:18 pm
As per some reference, European agency referred it as Unspecified Individual Impurity, in reporting the impurity result, are we just always concerned about Single Largest Impurity?
As it's the largest it (intuitively) potentially could do most damage.
That is the reason for the need for monitoring and potentially reducing the content of unknown compounds in a given product.
It is far from certain that the above would be the case, but if you’re bothered by this requirement you might like to characterize the compound in question and subsequently evaluate its potential harm.
Best Regards
