This Article Full Text (PDF) References Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Add to Saved Citations Download to citation manager Request Permissions Request Reprints Add to My Marked Citations Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Citing Articles via Scopus Google Scholar Articles by Poole, S. Articles by Gaines Das, R.E. Search for Related Content PubMed Articles by Poole, S. Articles by Gaines Das, R.E. Social Bookmarking                         What's this?

Second international standard for endotoxin: calibration in an international collaborative study

Division of Endocrinology, National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, UK

P. Dawson

Standards Processing Division, National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, UK

R.E. Gaines Das

Informatics Laboratory, National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, UK

On behalf of the World Health Organization, 26 scientists in 13 countries calibrated a candidate international standard for endotoxin and compared it with the Pharmacopoeial standards of the US, Europe and Japan. The study showed that the candidate standard is suitable to serve as the second international standard for endotoxin for all applications, with an assigned unitage of 10,000 international units (IU)/vial, with 1 IU = 1 EU (FDA/USP endotoxin unit). This value maintains continuity of unitage with EC5 (the primary calibrant for the first international standard), EC6 (the current FDA/USP standard), the Japanese Pharmacopoeia Standard and commercial preparations of Limulus lysate. This value is also consistent with calibration of the candidate standard in terms of the European Pharmacopoeia Standard, BRP-2. The establishment of this international standard for endotoxin will permit the global harmonisation of unitage for standards of endotoxin.

Journal of Endotoxin Research, Vol. 4, No. 3, 221-231 (1997)
DOI: 10.1177/096805199700400308


CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				G. Y. C. Cheung, D. Xing, S. Prior, M. J. Corbel, R. Parton, and J. G. Coote Effect of Different Forms of Adenylate Cyclase Toxin of Bordetella pertussis on Protection Afforded by an Acellular Pertussis Vaccine in a Murine Model Infect. Immun., December 1, 2006; 74(12): 6797 - 6805. [Abstract] [Full Text] [PDF]