Stability of ready-to-use temsirolimus infusion solution (100mg/L) in polypropylene containers under different storage conditions.

The aim of this study was to determine the stability of ready-to-use temsirolimus infusion solutions under different storage conditions. Solutions were prepared in polypropylene containers by adding temsirolimus injection to 0.9% sodium chloride infusion to reach a final concentration of 100mg/L. The following storage conditions were tested: (i) 4(o)C in the refrigerator; (ii) 20(o)C under room light exposure and light protection; and (iii) outdoor temperature with sunlight exposure. Moreover, stress testing was performed on drug substance at 20(o)C under ultraviolet (UV) radiation (365 nm). A stability-indicating high-performance liquid chromatography (HPLC) method with UV detection was developed for this analysis. Precision was below 4% and accuracy ranged from 97 to 102%. The lower limit of quantitation was 0.1mg/L. The degradation products produced after UV light exposure were detected upon further analysis by mass spectrometry detection. The stability of temsirolimus is light and temperature dependent. After storage at 20(o)C with room light exposure, the rate of degradation was around 0.25%/h; after 1 day, 92.5% of the initial temsirolimus concentration was recovered. When protected from light, at 4 and 20(o)C, losses were decelerated; the decrease in drug concentration was 1.0 and 1.56% per day, respectively. Under daylight exposure, a substantial decrease in drug concentration was observed; after 1h, losses were higher than 10%. Exposed to UV light, half of the drug was lost after 45 min. In conclusion, temsirolimus 100mg/L in infusion polypropylene bags containing 0.9% sodium chloride was chemically stable when protected from light for 4 and 3 days at 4 and 20(o)C, respectively.