Physicochemical stability of durvalumab (Imfinzi®) concentrate for solution in original vials after first opening

Abstract

Durvalumab (Imfinzi®), a PD-L1 monoclonal antibody (mAb) medication is available as concentrate (50 mg/mL) for solution for infusion. The summary of product characteristics provides information about the physicochemical stability of ready-to-administer durvalumab preparations (vehicle solution 0.9 % NaCl, G5%), but not about the concentrate after first opening. The objective of this study was to determine the physicochemical stability of durvalumab concentrate for solution after first opening over a period of 28 days.

Keywords

• concentrate for solution
• durvalumab
• ie-hplc
• physicochemical stability
• se-hplc
• temperature