REPORT CONCERNING THE COLABORATIVE STUDY FOR ESTABLISH OF REFERENCE STANDARD EFICACITY OF COLISTIMETHAT SODIUM
Journal Title: Medicamentul Veterinar / Veterinary Drug - Year 2010, Vol 4, Issue 1
Abstract
Institute for the Control of Veterinary Biological Products and Medicines participated at the collaborative study for determine the potency of colistimethate sodium CRS, Lot 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 colistimethate sodium 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 "Colistimethate sodium", 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, colistimethate sodium - reference materials, was established in 285000UI/vial.
Authors and Affiliations
Simona Sturzu, Daniela Tirinoaga, Rodica Stancu, Georgeta Stan
Keywords
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