title: Collaborative study for the establishment of the 4(th) International Standard for Streptomycin.
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).
authors.affiliation: European Directorate for the Quality of Medicines & HealthCare (EDQM), Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France, sylvie.jorajuria@edqm.eu.
authors.forename: S
authors.initials: S
authors.lastname: Jorajuria
authors.affiliation: European Directorate for the Quality of Medicines & HealthCare (EDQM), Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France.
authors.forename: C
authors.initials: C
authors.lastname: Raphalen
authors.affiliation: European Directorate for the Quality of Medicines & HealthCare (EDQM), Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France.
authors.forename: V
authors.initials: V
authors.lastname: Dujardin
authors.affiliation: European Directorate for the Quality of Medicines & HealthCare (EDQM), Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France.
authors.forename: A
authors.initials: A
authors.lastname: Daas
mesh_terms: D000900:Anti-Bacterial Agents / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D012015:Reference Standards; D013307:Streptomycin / Q000592:standards*; D014944:World Health Organization
chemical_list: D000900:Anti-Bacterial Agents; D013307:Streptomycin
keywords: Streptomycin; WHO International Standard; antibiotic; collaborative study; microbiological assay