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 Objectives 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 was to test solubility new MMC formulation with regard highly concentrated and determine clinically relevant concentrations stored under different conditions in various primary containers. Methods dissolved water for injection achieve 1 mg/mL 2 mg/mL. Additionally, were further normal saline obtain 0.2 0.4 solutions. According clinical practice, original glass vials mg/mL, plastic syringes. All either refrigerated or at 20–25 °C light protected up 8 days. Samples taken immediately after dissolution dilution predetermined time points. Physicochemical determined reversed-phase high-performance liquid chromatography (RP-HPLC) photodiode array detection, pH osmolality measurement, inspection visible particles color changes. Results achieved room temperature given h, independent storage temperature. Between 12 h storage, crystallization occurred almost all samples. In solutions, refrigeration, 3 4 days respectively. vial without signs crystallization, concentration amounted >90 % initial measured 6 When temperature, not seen, but declined below 90 limit about 15 storage. observed all. refrigerated, preparations physicochemically stable 5 days, least irrespective concentration. Conclusions enables preparation additional heating shaking due hydrotropic activity urea contained excipient. However, most dominant limiting factor, especially Hence, recommended this less prominent. avoid increased chemical degradation recommended. Both, should always be checked formation crystals before use. an issue extends maximum