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- Posts: 95
- Joined: Fri Nov 30, 2012 5:18 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?
