Any Unspecified Individual Impurity
Posted: Tue Sep 16, 2014 12:31 pm
When USP Says on their monograph "Any Unspecified Individual Impurity" and has a limit of not more than 0.1%, does it mean Single largest impurity only?
As a nitpicker i would say no, "any" impurity should really mean ANY impurity.When USP Says on their monograph "Any Unspecified Individual Impurity" and has a limit of not more than 0.1%, does it mean Single largest impurity only?
From a practical point of view I would say it doesn't really matter that much since, if your largest impurity is >0.1%, it's an OOS! For the status of the product, does it matter if there's more than one impurity violating the specification?