title: Collaborative study for the establishment of the 3rd international standard for dihydrostreptomycin.
abstract: An international collaborative study was organised to establish the World Health Organization (WHO) 3rd International Standard (IS) for dihydrostreptomycin. Eleven laboratories from different countries participated in the collaborative study. The potency of the candidate batch, a freeze-dried preparation, was estimated by microbiological assays with sensitive microorganisms. To ensure continuity between consecutive batches of the WHO IS, the 2nd IS for dihydrostreptomycin was used as standard. Based on the results of the study, the 3rd IS for dihydrostreptomycin was adopted at the meeting of the WHO Expert Committee on Biological Standardisation (ECBS) in 2011 with an assigned anti-microbiological activity of 19425 International Units (IU) per vial. The 3rd IS for dihydrostreptomycin is available from the EDQM.
authors: European Directorate for Quality of Medicines & HealthCare, Council of Europe, Strasbourg, France. guy.rautmann@edqm.eu
authors: G
authors: G
authors: Rautmann
authors: A
authors: A
authors: Daas
authors: K-H
authors: KH
authors: Buchheit
mesh_terms: D000900:Anti-Bacterial Agents / Q000737:chemistry / Q000494:pharmacology / Q000592:standards*; D055598:Chemical Phenomena; D003627:Data Interpretation, Statistical; D004096:Dihydrostreptomycin Sulfate / Q000737:chemistry / Q000494:pharmacology / Q000592:standards*; D004355:Drug Stability; D005060:Europe; D007391:International Cooperation; D007753:Laboratories / Q000592:standards; D008826:Microbial Sensitivity Tests / Q000592:standards*; D010602:Pharmacopoeias as Topic; D011786:Quality Control; D012015:Reference Standards; D014944:World Health Organization
chemical_list: D000900:Anti-Bacterial Agents; D004096:Dihydrostreptomycin Sulfate