Stability of Captisol-enabled versus propylene glycol-based melphalan at room temperature and after refrigeration.

Purpose: To compare the chemical stability of Captisol-enabled (CE) melphalan ("CE-melphalan"; Evomela, Acrotech Biopharma LLC) and propylene glycol (PG)-based melphalan ("PG-melphalan"; Alkeran, GlaxoSmithKline) admixtures prepared with 0.9% sodium chloride injection in polyvinyl chloride (PVC) bags or reconstituted vials stored at room temperature (RT) and under refrigeration.

Methods: Lyophilized CE-melphalan and generic PG-melphalan were reconstituted to 5 mg/mL with 0.