Producing a sulfamethazine quality control material under the framework of ISO/CD Guide 80

The increasing use of antimicrobial agents such as sulfonamides by the pig industry is of concern, since residues in both pork and its by-products, when derived from animals treated improperly, can endanger human health. The aim of this study was to establish the production conditions and to evaluate the homogeneity and the stability of sulfamethazine in porcine liver quality control material, produced 'in-house' for use in ring tests of the laboratory network of residues and contaminants of the Ministry of Agriculture, Livestock and Food Supply, Brazil. In the process of preparing the material, a FOSS blender was used, where the samples were ground to obtain a homogeneous mass, which was packed in polypropylene bottles. The material resulting from this process of homogenisation was sampled and analysed by LC/MS/MS. The analytical results were statistically evaluated by one-way ANOVA. According to statistical evaluation, the material produced was considered homogeneous, with 95% confidence. Stability tests were performed with the bottles stored under the specified storage conditions. They were randomly selected and analysed in duplicate by the same analytical method as the homogeneity study. The analytical results were statistically evaluated by the procedures for a stability check described in ISO 13528:2005, indicating that the material was unstable under the conditions of storage.