Page 1 of 1
Related substance again
Posted: Mon Dec 04, 2006 5:20 pm
by mfahe
thanks very much for your response
but i have an a qus. is it a spesific limit for impurity which can i detect in product or material? and if it is how has it been knewn?
Posted: Mon Dec 04, 2006 6:40 pm
by DR
Generally speaking, in pharma - Any peak that is >0.05 area % vs. API peak is watched on stability studies while anything over 0.1 area % is identified (and also watched).
Posted: Tue Dec 05, 2006 9:26 am
by PJ8
Or >0.03 % for a high does compound.
It depends on the daily dose
Posted: Tue Dec 05, 2006 1:38 pm
by gbalock
The ICH Guideline are fairly clear on this (Q3B(R2)). It depends on your maximum daily dose of the drug. There's a great decision chart at the end of this guidance. Here is the link for it.
http://www.ich.org/cache/compo/276-254-1.html