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Published on: August 31, 2015
Collaborative study for the establishment of the 2nd international standard for neomycin B
S Jorajuria1, C Raphalen2, V Dujardin2
1European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France, sylvie.jorajuria@edqm.eu.
Abstract:
An international collaborative study was organised to establish the World Health Organization (WHO) 2nd International Standard (IS) for neomycin B. Seven laboratories from different countries participated. Potencies of the candidate material were estimated by microbiological assays with sensitive micro-organisms. To ensure continuity between consecutive batches of the WHO IS, the 1st IS for neomycin B was used as reference. Based on the results of the study, the 2nd IS for neomycin B was adopted at the meeting of the WHO Expert Committee for Biological Standardization (ECBS) in 2012 with an assigned potency of 17640 International Units (IU) per vial. The 2nd IS for neomycin B is available from the European Directorate for the Quality of Medicines & HealthCare (EDQM).
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