WHO/BS/2019.2375 Collaborative Study for the Establishment of the Third IS for Amphotericin B

Overview

This report describes the results and the outcome of an international collaborative study organised to establish the third World Health Organization (WHO) International Standard (IS) for Amphotericin B. Sixteen (16) laboratories from different countries participated. The potency of the candidate material was estimated by microbiological assays with sensitive microorganisms. To ensure continuity between consecutive batches, the second IS for Amphotericin B 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).