Limulus amoebocyte lysate assay for detection and quantitation of endotoxin in a small-volume parenteral product-Reference-Cited by-同舟云学术

Limulus amoebocyte lysate assay for detection and quantitation of endotoxin in a small-volume parenteral product

Published:1980-09 Issue:3 Volume:40 Page:533-538
ISSN:0099-2240
Container-title:Applied and Environmental Microbiology
language:en
Short-container-title:Appl Environ Microbiol

Author:

Tsuji K,Steindler K A,Harrison S J

Abstract

A Limulus amoebocyte lysate gel-clotting method for the determination of endotoxin in a small-volume parenteral product has been described. Sample dilution with 0.1 M potassium phosphate monobasic buffer (pH 8.0) effectively eliminated assay interference, whereas dilution with water did not. The threshold pyrogenic dose for Escherichia coli EC-2 and O127:B8 endotoxins was determined to be 1.0 ng of endotoxin per kg of body weight. Not more than 1.0 ng of endotoxin (the threshold pyrogenic dose) per the highest recommended human dose or the USP pyrogen test dose per kg of body weight, whichever dose is more stringent, is a logical limit for the quantity of bacterial endotoxin in small-volume parenteral products. Excellent correlation was attained when this criterion was used to compare the Limulus amoebocyte lysate assay with the USP pyrogen test.

Publisher

American Society for Microbiology

Subject

Ecology,Applied Microbiology and Biotechnology,Food Science,Biotechnology

Link

https://journals.asm.org/doi/pdf/10.1128/aem.40.3.533-538.1980

Reference17 articles.

1. Some problems of pyrogen testing;Braun H. A.;Bull. Parenter. Drug Assoc.,1960

2. Comparative pyrogenic reactivity of rabbit and man to bacterial endotoxin;Greisman S. E.;Proc. Soc. Exp. Biol. Med.,1969

3. Harrison S. J. K. Tsuji and R. M. Enzinger. 1979. Application of LAL for detection of endotoxin in antibiotic preparations p. 353-365. In E. Cohen (ed.) Biomedical applications of the horseshoe crab (Limulidae). Alan R. Liss Inc. New York.

4. Health Ilidustry Manufacturers Association. 1979. HIMA collaborative study for the pyrogenicity evaluation of a reference endotoxin by the USP rabbit test. Health Manufacturers Association Washington D.C.

5. Further developments of Limulus amebocyte Iysate test;Hochstein H. D.;Bull. Parenter. Drug Assoc.,1973

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