Chromatography Forum

Posted: **Thu Mar 03, 2005 8:04 pm**

Hi,
I couldn't find any information about limit of dissolution in European Pharmacopia but there are limits in USP.
Do you know if there is a supplement of Eu.Ph. about it?
Thanks...

Posted: **Fri Mar 04, 2005 6:34 pm**

Nihal,

The EP/BP generally do not give limits in their monographs. Instead, the EP has a chapter for dissolution (similar to USP<711>) where the limit for a dissolution test is given.

EP 2.9.3 Dissolution test for tablets and capsules:
Take samples at 45 minutes
For each of the six tablets (or capsules), the limit is not less than 70%
If one unit fails the requirements. six more units may be tested and all must comply.
No further retesting is permitted.

This is all changing as the EP, JP and USP have reached agreement on harmonization of dissolution testing.

For further info and questions, you should check out the Dissolution Discussion Group at:
http://www.dissolution.com/

Regards,
Dan