Collaborative study for the establishment of the WHO 3rd international standard for Endotoxin, the Ph. Eur. endotoxin biological reference preparation batch 5 and the USP Reference Standard for Endotoxin Lot H0K354

Last updated on 22-8-2019 by Anonymous (non vérifié)

Sci. report, recommendat°, guidance doc., directive, monograph



An international collaborative study was organised jointly by the World Health Organization (WHO)/National Institute for Biological Standards and Control (NIBSC), the United StatesPharmacopeia (USP) and the European Directorate for the Quality of Medicines & HealthCare (EDQM/Council of Europe) for the establishment of harmonised replacement endotoxinstandards for these 3 organisations. Thirty-five laboratories worldwide, including Official Medicines Control Laboratories (OMCLs) and manufacturers enrolled in the study. Threecandidate preparations (10/178, 10/190 and 10/196) were produced wit…

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