Dear Friends;

I would like to hear about any good literature references, reviews, or official regulations, applied on studies of this type. I am not talking necessarily about HPLC methods, I am more interested on conditions (temperature, humidity, pH, light), times, stress conditions, etc.

Please reply directly to:

analchembe@aol.com


Thanks for your help;

Benjamin

1) Current USP/NF
2) FDA guidance at http://www.fda.gov/cder/regulatory/default.htm
3) ICH at http://www.ich.org