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The International Standard for Endotoxin: evaluation in an international collaborative study
1National Institute for Biological Standards and Control, Hertfordshire, UK.
Journal of Biological Standardization
|April 1, 1989
Summary
A new bacterial endotoxin standard (84/650) was established as the International Standard for Endotoxin for Limulus Gelation Tests. This standard provides a unitage of 14,000 IU per ampoule for global use.
Area of Science:
- Microbiology
- Immunology
- Pharmacology
Background:
- Bacterial endotoxins are critical components of Gram-negative bacteria.
- Accurate quantification of endotoxins is essential for pharmaceutical safety and research.
- Existing standards require international harmonization for reliable testing.
Purpose of the Study:
- To evaluate a candidate preparation (84/650) for its suitability as the International Standard for Endotoxin.
- To calibrate the candidate standard against the USA National Standard (EC5).
- To establish a globally recognized standard for endotoxin testing.
Main Methods:
- Multicenter international collaborative study involving 35 laboratories across 12 countries.
- Calibration using Limulus Amoebocyte Lysate (LAL) assays: gelation, turbidimetric, and chromogenic tests.
- Inclusion of rabbit pyrogen tests for comprehensive evaluation.
Main Results:
- Preparation 84/650 demonstrated suitability for international standardization.
- Consistent results were obtained across various LAL assay formats and in vivo pyrogen tests.
- The preparation was authorized by the World Health Organization's Expert Committee on Biological Standardization.
Conclusions:
- Preparation 84/650 was established in 1986 as the International Standard for Endotoxin for Limulus Gelation Tests.
- An assigned unitage of 14,000 IU of endotoxin per ampoule was determined.
- This standard facilitates global consistency and accuracy in endotoxin quantification.