Influence of radiation sterilization on the stability of trifluorothymidine.

The influence of radiation sterilization on the stability of trifluorothymidine (TFT) was investigated. TFT was irradiated under ambient atmosphere with a 60Co-source and with an electron accelerator at 25, 50, and 100 kGy, respectively. The radiation-induced effects were determined by chromatographic and spectroscopic methods as well as potentiometrically with a fluoride selective electrode. TFT was moderately stable to ionizing radiation. The degradation induced by electron-beam irradiation was significantly (P=95%) smaller than by gamma-irradiation. The radiolysis products amounted to about 0.25% after electron-beam irradiation at 25 kGy, and to about 0.50% after gamma-irradiation, respectively. The main irradiation product was 5-trifluoromethyluracil (TFMU). In addition five further impurities were detected with HPLC. Identification of degradation products was performed using HPLC-ESI-MS. A degradation path of TFT after radiation sterilization was shown.