THE PRODUCTION OF PIG-TISSUE SULFADIMIDINE REFERENCE MATERIAL

The production of stable homogeneous reference materials containing th e antimicrobial agent sulphadimidine in pig tissue is described. These were commissioned by the Community Bureau of Reference (BCR), establi shed by the Commission of the European Communities, to promote improve ments in analytical accuracy and to ensure uniformity of results deter mined by member states. Sulphadimidine-containing tissue powders (400 vials each of muscle, liver and kidney) were prepared by orally dosing pigs with drug, producing lyophilized tissue powders and blending the se with negative tissues from unmedicated animals to achieve target co ncentrations. Details of the production process, the stabilizing proce dure developed and the analytical assessments of homogeneity and stabi lity are given.