Report concerning the colaborative study for establish of reference standard eficacity of Teicoplanin
2015
Simona Sturzu | Daniela Tîrsînoagă | Ioana Tihulcă | Mariana Dumitrache | Alina Drăghici | Valentina Năstase
The Microbiology Laboratory from the Institute for the Control of Veterinary Biological Products and Medicines participated to a collaborative study in order to determine the potency of teicoplanin CRS, batch 2, according to the protocol sent by the EDQM (European Directorate for the Quality of Medicines) - coordinator of the study. The purpose of the study was to determine the potency of the batch 2 teicoplanin in the characterization of the substance as reference standard. Potency was determined by microbiological method, based on comparing 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 2, teicoplanin - reference materials, was established in 50150UI/fiola.
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