Certified Reference Material of Tylosin Tartrate

Antibiotics are widely used to combat various infectious diseases in animals. The uncontrolled use of antibiotics leads to antibiotic residues in food products that are easily transmitted to humans through food chains. The quality of medicinal products and the food safety of animal products is controlled by determining the content of drug residues using reference materials (RMs). In this study, we develop a certified RM (CRM) for the composition of tylosin tartrate. The methodology involved selection of a procedure for preparing the initial RM and methods for measuring the content of tylosin tartrate. As a result, HPLC was used for quantitative determination of the certified value of the measured quantity (mass fraction of tylosin). In accordance with RMG 93-2015 and GOST ISO Guide 35-2015, the standard uncertainty of the RM certified value from the characterization method, heterogeneity and instability of the material was estimated. The expanded uncertainty of the certified value was calculated. A new CRM GSO 11632-2020 for the composition of tylosin tartrate was approved. The CRM can be used for certifying measurement methods and controlling the measurement results of the mass fraction of tylosin in veterinary medicinal products, food, and animal feed.