Physicochemical stability of urea-containing Mitomycin C preparations in glass vials (1.0 mg/mL) and plastic syringes (2.0, 0.4, 0.2 mg/mL)

Abstract

To date, there is only one study investigating the physicochemical stability of diluted mitomycin (MMC) solutions prepared by using urea-containing Mitomycin medac as starting material. The aim of the study was to test the solubility of the new MMC formulation with regard to highly concentrated solutions and determine the physicochemical stability of clinically relevant MMC concentrations stored under different conditions in various primary containers.

Keywords

• high-performance liquid chromatography (hplc) assay
• mitomycin c
• physicochemical stability
• plastic syringes
• solubility
• urea-containing formulation