Force Degradation

[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

[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.

[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

[bartjoosen]

Which Pharm Tech? Maybe you can post a link to the article?

[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.

[JA]

Can't find it. Can you help?

[JM]

well i can help!!!!

http://www.pharmtech.com/pharmtech/arti ... ?id=146294

should work!!

JM