Abstract

In a study of the relevant literature the results obtained by experimental irradiation from more than 400 pharmaceuticals were compiled and discussed. The results of the relevant dose range which for sterilization purposes are between 1 Mrd (10 kGy) and 6 Mrd (60 kGy;) show the following tendencies: after irradiation of solid substances, the pharmaceuticals showed by more than 90% either no decomposition or a decomposition up to 2% only. In aqueous solution, irradiation of all agents resulted in a more or less intense radiolysis. A comparison of sterilization by heating and irradiation was done with approximately 50 substances; as regards the preferable procedure, the results are not consistent. In many cases quantitative data on the number and percentage of the decomposition products are not available. The radiolysis products were identified in very few examinations, and finally there ist almost no examination which considers the extremely important aspect of a toxicological or pharmacological analysis or evaluation of the irradiated drugs.

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