Stability of an injectable disulfiram formulation sterilized by gamma irradiation

Stability of an injectable disulfiram suspension sterilized by gamma(gamma) irradiation was tested. Single doses of disulfiram powder in plastic syringes were subjected to 50,000 rads of gamma radiation. Culture media were inoculated with the irradiated drug to test for growth of bacteria, fungi, and mycobacteria. The irradiated drug and nonirradiated controls were analyzed by high-performance liquid chromatography (HPLC) for disulfiram and its major degradation product, diethyldithiocarbamate (DDC). Ultraviolet absorption spectra of irradiated and nonirradiated disulfiram were obtained. No organisms grew in any of the culture media. HPLC analysis indicated that disulfiram content of the irradiated specimens was not reduced, and DDC was not detected. There were no important differences between the ultraviolet spectra of the irradiated and nonirradiated samples. Disulfiram can be sterilized by gamma irradiation without chemical degradation.