Bioequivalence and Bioavailability Forum

Dear Keshav,

For small molecules this is currently not required by any guideline. It is generally considered that if you have demonstrated stability at -20°C, it will cover lower temperatures too. There have been some discussions about the possible effect of CO₂ on the pH of the samples and from there on stability, but as far as I know no regulatory agency asks for stability on dry ice.

For large molecules (proteins) there is much more debate due to the possible influence of variations in temperature on the structure of the proteins.

Regards
Ohlbe