Collaborative study for the establishment of the 2nd International Standard for Bleomycin Complex A2/B2

摘要

An international collaborative study was organised to establish the 2nd World Health Organization (WHO) International Standard (IS) for bleomycin complex A2/B2. Eight 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 1st IS for bleomycin complex A2/B2 was used as a reference. Based on the results of the study, the 2nd IS for bleomycin complex A2/B2 was adopted at the meeting of the WHO Expert Committee for Biological Standardization (ECBS) in 2014 with an assigned potency of 12 500 International Units (IU) per vial. The 2nd IS for bleomycin complex A2/B2 is available from the European Directorate for the Quality of Medicines & HealthCare (EDQM).