WHO/BS/2015.2277 Collaborative Study for the Establishment of the 4th IS for Streptomycin

Overview

This report describes the results and the outcome of an international collaborative study organised to establish the fourth World Health Organization (WHO) International Standard (IS) for Streptomycin. 14 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 third IS for Streptomycin was used as reference.

This report provides details about the material donated by a manufacturer, the processing involved to generate a candidate batch and the analytical controls to assess its quality. It includes statistical analysis of the results, the conclusions made thereof and a recommendation to the WHO Expert Committee for Biological Standardization (ECBS).

It is proposed that the fourth WHO International Standard for Streptomycin (EDQM internal code ISA_55821) be assigned an antimicrobiological activity of 76 000 IU/vial