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Force Degradation
Posted: Mon Mar 07, 2005 5:46 pm
by okara
Hi,
Can any one help me out; I am doing force degradation on drug substance. The compound is very stable and i did not see any degradation even at 10% H2O2 @ 100 degree centigrade. Please help me out if you know any other condition. The compound is not soluble in water
Thanks
Posted: Mon Mar 07, 2005 10:10 pm
by maris
Our policy in such a cases is: we declare that the compound doesn't ungergo the specific degradation and no decomposition products can be expected. Don't forget - the forced degradation study is intended for generation of potential degradation products,which many times aren't actual, so, what can we expect if the substance is stable under stress conditions - of course, that it will be much more stable (i.e. no decomposition products at accelerated/long term) and you can stay with the method that sucessfully separates the rest.
Posted: Tue Mar 08, 2005 3:15 pm
by adam
I would agree.
In fact there was a recent paper in Pharm. Tech. that summarized the conclusions of a workforce that was put together to evaluate the issue of forced degradation. In the article they emphasized that one should use 'purposeful degradation'. Meaning that you only want to form degradation products that you would expect to see in the course of stability.
Adam
Posted: Wed Mar 09, 2005 9:15 am
by bartjoosen
Which Pharm Tech? Maybe you can post a link to the article?
Posted: Wed Mar 09, 2005 3:04 pm
by adam
I don't have the article handy. But it was very recent. Either the last issue or the one before that.
Should be easy to find.
Posted: Thu Mar 31, 2005 9:54 pm
by JA
Can't find it. Can you help?
Posted: Fri Apr 01, 2005 6:16 am
by JM
