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Impurity limit
Posted: Tue Nov 15, 2005 2:50 pm
by salfar
Dear all,
Can anyone tell me how can I define the limit for the summ of all impurities of a drug substance and a drug product? I have searched in the guideline, but I didn't found it...
Thank you in advance,
Sonia
Posted: Wed Nov 16, 2005 6:48 pm
by tom jupille
No single limit. Depends on the spec for purity of the drug product. If, for example, it's 99%, then the impurities must total <1%. Look something like the USP monographs to give you an idea of what's generally expected.
Posted: Tue Nov 22, 2005 11:38 pm
by Sallybeetle
The FDA has released a new Impurities draft guidance called "ANDAs: Impurities in Drug Products."
The guidance is derived from the ICH (International Conference on Harmonization) November 2003 guidance "Q3B(R) Impurities in Drug Products."
An article on this appears in the October 2005 issue of Pharmaceutical Technology Magazine.
Hope this helps. I find reading the ICH guidelines very helpful in method and product development work.
Posted: Tue Nov 22, 2005 11:41 pm
by Sallybeetle
Since I mentioned the FDA and ICH guidance documents in my last post, here are the websites to make your search easier.
FDA Guidance Documents:
http://www.fda.gov/cder/guidance/index.htm
ICH Guidance Documents:
http://www.ich.org/cache/compo/276-254-1.html
Lots of luck in your search. Don't fall asleep at the computer reading all these guidance documents.
Posted: Wed Nov 23, 2005 5:15 am
by Oliver
Hi Sallybeetle, thanks a lot for the links they are interesting.