Design of the Stability Study

For this descriptive, laboratory-based physicochemical stability study, a series of three independent syringes were prepared for each tested concentration. An aliquot (4 mL) of solution was withdrawn from the syringe immediately following incubation (baseline), and at 1, 2, 3, 4, 5 and 6 h during storage at 37 °C. MMC solutions were considered physically and chemically stable if there were no changes in physical characteristics, and if ≥90% initial drug concentration (≤10% degradation) was retained in samples.