A general insight is given on the composition of pharmaceutical rubber formulations. From there on, a list of predictable extractables and leachables can be given. Results are presented on the extractables of an Exxpro based rubber formulation in Water-for-lnjection before and after gamma irradiation. Exxpro is the trade name of an unconventional type of brominated elastomer, that is synthesized starting from isobutylene and p.methylstyrene as monomers. The pharmacopeial level of extractables for this rubber formulation (FM457) has been determined, as well as the influence of gamma irradiation doses up to 50 kGy on this. On a more detailed level the impact of gamma irradiation on the extractables profile in an organic solvent has been determined. Obtaining extractables information on irradiated rubber parts is recommended for Ready-To-Use applications, where rubber closures are sterilized by gamma irradiation.
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