quantitation of container leachables/extractables
Posted: Wed Oct 07, 2009 2:01 pm
Hi
We are currently quantitating leachables by minusing the peak area of the glass control away from the peak area of the sample if the difference between the two peaks is greater than 30%.
Our in house SOP states the 30% but we are wondering if other companies are applying the same rule.
How are others dealing with quanitiation of leachables?
thanks
Karen
We are currently quantitating leachables by minusing the peak area of the glass control away from the peak area of the sample if the difference between the two peaks is greater than 30%.
Our in house SOP states the 30% but we are wondering if other companies are applying the same rule.
How are others dealing with quanitiation of leachables?
thanks
Karen