Collaborative study for the establishment of the 3rd international standard for amphotericin B

An international collaborative study was organised to establish the 3rd World Health Organization (WHO) International Standard (IS) for amphotericin B. Sixteen 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 2nd IS for amphotericin B was used as a reference. Based on the results of the study, the 3rd IS for amphotericin B was adopted at the meeting of the WHO Expert Committee for Biological Standardization (ECBS) in 2019 with an assigned potency of 953 International Units (IU) per mg. The 3rd IS for amphotericin B is available from the European Directorate for the Quality of Medicines & HealthCare (EDQM).