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okay the first question at what level should an impurity be included in the drug substance specification hi um this is a good question um for just substance within the scope of ice hq3a any impurity greater than the identification stress code should be included in the specification if the impurity is unusually potent or toxic the stress code to list the impurity in the specification is determined on case-by-case basis thank you thank you for responding to that question the next question as for direct comparison to rld in d2s01 slide number 11 of your presentation does that mean direct comparison of generic drug substance versus innovative drug product or should it be a generic drug product versus an innovative drug product and yes it is the comparison between drug substance and the innovative drug product thank you thank you for responding to that question the next question for dr lye if the usp monograph does not have a list of specified impurities can we use other compendia such as e