Comment from Pooja Bhatt
AnonymousOtherIndividual
Summary: The commenter points out that the draft guidance fails to address unidentified impurities or degradation products. They specifically note the lack of detailed discussion regarding establishing limits for unspecified impurities that fall above the identification threshold.
The recommendations in the guideline does not address following:
-The recommendations are for specified impurities/degradation products, not clarifying for specified unidentified impurities/degradation products
-No detailed discussion for establishing limit above Identification threshold for any unspecified impurity/degradation product