Report concerning the colaborative study for establish of reference standard eficacity of Rifamycin

Abstract

The Microbiology Laboratory from the Institute for the Control of Veterinary Biological Products and Medicines participated in a collaborative study in order to determine the potency of rifamycin CRS, batch 4, according to the protocol sent by the EDQM (European Directorate for the Quality of Medicines) - coordinating of the study. The purpose of the study was to establish the potency of the batch 4 rifamycin in the characterization of the substance as reference standard. Potency was determined by microbiological method, based on comparison of the inhibition zones of growth of micro-organisms sensitive to those of a reference standard, as specified in European Pharmacopoeia, Chapter 2.7.2. - Microbiological testing of antibiotics. After analysis of received data from participants and their statistical processing by the EDQM, the potency of the batch 4, rifamycin - reference materials, was established in 870 UI/mg.