Stability of Drugs and Dosage Forms Sumie Yoshioka

5.3. • Degradation Kinetics of Peptide and Protein Pharmaceuticals 203
Arrhenius plots were also observed for the denaturation of β -galactosidase in solution. 890
These linear Arrhenius 'plots suggest that prediction of denaturation rate by accelerated
testing is possible if the denaturation mechanism does not change in the temperature range
in question. Because peptide and protein drugs generally denature via complicated mechanisms
(thermal denaturation, denaturation at interfaces, etc.), denaturation at lower temperature
may occur via mechanisms different from those at higher temperature. This makes it
difficult to predict the stability of peptide and protein drugs by accelerated testing. In cases
where only thermal denaturation occurs, however, prediction of denaturation rate by accelerated
testing may be possible.