Purpose: To study the degradation of human insulin induced upon irradiation at radiosterilization doses (10 kGy). Results: The chemical analysis of irradiated solid-state insulin by EPR, chromatography and circular dichroism has shown the radioresistance of human insulin at 10 kGy: radical yield ca. 10-9 mole.J-1, human insulin content > 95 %, low percentage of various degradation products. However, in aqueous solution, the degradation of human insulin was high at 10 kGy. The addition of radioprotecting excipients and cryoirradiation reduced insulin degradation. A satisfactory content of human insulin (>90 %) may only be achieved by a combination of these two methods. Conclusion: At solid-state, from a chemical analysis viewpoint, radiosterilization of human insulin is feasible at 10 kGy. In aqueous solution, radiosterilization of human insulin could be considered but should require an appropriate formulation and cold irradiation process.
Terryn, H. (2006). Contribution de l’analyse chimique à la description de la radiolyse des protéines : radiostérilisation des protéines. https://hdl.handle.net/2078.5/112151