I'm interested in learning what the FDA requires for identifying unknown degradants above 0.1% in ones drug formulation. Is there a source for the exact data needed? does your structure identification have to be confirmed by another source(lab)? Any help pointing me in the right direction would be great. I have access to a LC/MS/MS for identifying my unknown degradation products, but have to prove to my supervisor that the data and structure analysis I provide is acceptable for FDA submition. Thanks for your help

LC/MS/MS is a good start. Next steps: Either buy or make more of whatever it is you have ID'd and confirm that it behaves in the same manner as the degradant(s) in your drug samples when fed to the LC/MS/MS as well as to other instruments (think in terms of orthogonal techniques here). Then go see if any tox studies have been done on it (them).