A discussion of the factors influencing peptide stability illustrates
the challenges of formulation and shelf-life prediction which face bio
technologists. The activation energies of peptide degradation vary wit
h pH and moisture content. Peptide degradation rates are influenced by
both buffer type and concentration. Lyophilization results in an incr
ease in buffer concentration which also enhances peptide degradation i
n low-moisture solids. Small peptides have degradation rates that depe
nd upon water activity rather than upon mobility limitations associate
d with the state of the system. The pH-rate profiles for peptide degra
dation in solution and solids are quite different. Dehydration and par
tial rehydration change the pH of reduced-moisture solids, which chang
e both the rates and mechanisms of degradation. The properties of the
peptide and the system as well as potential interactions between the t
wo need to be identified to maximize peptide stability. In addition, s
olution data cannot be used to predict the shelf Life of reduced-moist
ure solids.