API and Related Impurities

[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).

[gbalock]

Nalizer,
I find that the EP has good listings of impurities for API's.

[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...