SUMMARY
Background: The radiation sterilization is one of the best methods for sterilizing vulnerable degradation drugs like
cefozopran hydrochloride.
Results: Chemical stability of radiosterylized cefozopran hydrochloride, was confirmed by spectrophotometric
and chromatographic methods. EPR studies showed that radiation has created some radical defects whose
concentration was no more than several dozen ppm. The antibacterial activity of cefozopran hydrochloride
irradiated with a dose of 25 kGy was unaltered for Gram-positive bacteria but changed for two Gram-negative
strains. The radiation sterilized cefozopran hydrochloride was not in vitro cytotoxic against human CCD39Lu
normal lung fibroblast cell line.
Conclusions: Cefozopran hydrochloride in solid state is not resistant to radiation sterilization and this method
cannot be used for sterilization of this compound.