Collaborative study for the establishment of the 4(th) International Standard for Streptomycin.

Pharmeur Bio Sci Notes

European Directorate for the Quality of Medicines & HealthCare (EDQM), Department of Biological Standardisation, OMCL Network & HealthCare (DBO), Council of Europe, Strasbourg, France.

Published: December 2016

AI Article Synopsis

  • An international study involved 14 labs from different countries to establish the 4th WHO International Standard for Streptomycin.
  • Microbiological assays were conducted using the 3rd standard as a reference to estimate the potencies of the candidate material.
  • The new standard, adopted in 2015, was assigned a potency of 76,000 International Units per vial and is available from the EDQM.

Article 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).

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