Engalytcheff A
radiolysis of solid-state grugs and the analytical tools applicable to this study.
chimie nouvelle (2007) 94:2-7

Abstract:

The use of ionizing irradiation is a technique recommended by the Pharmacopoeias to sterilise solid-state drugs. Its high efficiency (security assurance level of 10e-6) combined to a limited rise of temperature make it the next best choice after heat technique. Its main drawback lies in the production of unique impurities in small quantities. These products have been investigated through various analytical techniques, which are described and compared in this review. On the contrary of the irradiation of food, no protocols are defined yet. Analyses are though necessary either to determine the feasibility of radiosterilization or to control the quality of the irradiated drug and common procedures should be established. In this perspective, we will therefore conclude by characterising the most appropriate methods.