ABSTRACT
An international collaborative study was organised to establish the 4(th) World Health Organization (WHO) International Standard (IS) for Streptomycin. Fourteen 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, the 3(rd) IS for Streptomycin was used as a reference. Based on the results of the study, the 4(th) IS for Streptomycin was adopted at the meeting of the WHO Expert Committee for Biological Standardization (ECBS) in 2015 with an assigned potency of 76 000 International Units (IU) per vial. The 4(th) IS for Streptomycin is available from the European Directorate for the Quality of Medicines & HealthCare (EDQM).
Subject(s)
Anti-Bacterial Agents/standards , International Cooperation , Streptomycin/standards , World Health Organization , Humans , Reference StandardsABSTRACT
Organization (WHO) International Standard (IS) for bleomycin complex A2/B2. Eight 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, the 1(st) IS for bleomycin complex A2/B2 was used as a reference. Based on the results of the study, the 2(nd) IS for bleomycin complex A2/B2 was adopted at the meeting of the WHO Expert Committee for Biological Standardization (ECBS) in 2014 with an assigned potency of 12 500 International Units (IU) per vial. The 2(nd) IS for bleomycin complex A2/B2 is available from the European Directorate for the Quality of Medicines & HealthCare (EDQM).
Subject(s)
Anti-Bacterial Agents/standards , Bleomycin/standards , International Cooperation , World Health Organization , Humans , Reference StandardsABSTRACT
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).
