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API and Related Impurities

Posted: Sun Oct 22, 2006 11:34 pm
by Nalizer
Dear All,

I am looking for sources (USP, journals, etc.) describing API and related impurities for drugs already on the market, including drugs under patent protection and generic drugs. Looking for detailed description of actives and major impurities (structures, amounts in each drug, and toxicology of impurities).

Check out the EP

Posted: Mon Oct 23, 2006 4:58 pm
by gbalock
Nalizer,
I find that the EP has good listings of impurities for API's.

Posted: Mon Oct 23, 2006 5:06 pm
by DR
You might have to go through the freedom of information act adn even then, impurity profiles may or may not be redacted in copies of SBAs...