Literature DB >> 6448582

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

K Tsuji, K A Steindler, S J Harrison.   

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.

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Year:  1980        PMID： 6448582      PMCID： PMC291618          DOI： 10.1128/aem.40.3.533-538.1980

Source DB:  PubMed          Journal:  Appl Environ Microbiol        ISSN： 0099-2240            Impact factor:   4.792


  9 in total

1.  THE ROLE OF ENDOTOXIN IN THE EXTRACELLULAR COAGULATION OF LIMULUS BLOOD.

Authors:  J LEVIN; F B BANG
Journal:  Bull Johns Hopkins Hosp       Date:  1964-09

2.  Observations on the pyrogenic response and its application to the bioassay of endotoxin.

Authors:  W R KEENE; H R SILBERMAN; M LANDY
Journal:  J Clin Invest       Date:  1961-02       Impact factor: 14.808

3.  Application of LAL for detection of endotoxin in antibiotic preparations.

Authors:  S J Harrison; K Tsuji; R M Enzinger
Journal:  Prog Clin Biol Res       Date:  1979

4.  Applications and advantages of the Limulus amebocyte lysate (LAL) pyrogen test for parenteral injectable products.

Authors:  C C Mascoli; M E Weary
Journal:  Prog Clin Biol Res       Date:  1979

5.  Comparison of limulus amebocyte lysates and correlation with the United States Pharmacopeial pyrogen test.

Authors:  R E Wachtel; K Tsuji
Journal:  Appl Environ Microbiol       Date:  1977-06       Impact factor: 4.792

6.  Factors affecting the sensitivity of Limulus lysate.

Authors:  J D Sullivan; S W Watson
Journal:  Appl Microbiol       Date:  1974-12

7.  Further developments of Limulus Amebocyte Lysate test.

Authors:  H D Hochstein; R J Elfin; J F Cooper; E B Seligmann; S M Wolff
Journal:  Bull Parenter Drug Assoc       Date:  1973 May-Jun

8.  Comparative pyrogenic reactivity of rabbit and man to bacterial endotoxin.

Authors:  S E Greisman; R B Hornick
Journal:  Proc Soc Exp Biol Med       Date:  1969-09

9.  Inhibitory effect of heparin on the Limulus test for endotoxin.

Authors:  J D Sullivan; S W Watson
Journal:  J Clin Microbiol       Date:  1976-08       Impact factor: 5.948
  9 in total
  8 in total

1.  Novel endotoxin assay by laser light-scattering particle-counting method.

Authors:  Kotaro Mitsumoto; Katsumi Yabusaki; Koji Kobayashi; Yoshiaki Shirasawa; Toru Obata
Journal:  J Clin Lab Anal       Date:  2009       Impact factor: 2.352

2.  Comparison of the standard pour plate procedure and the ATP and Limulus amebocyte lysate procedures for the detection of microbial contamination in intravenous fluids.

Authors:  R L Anderson; A K Highsmith; B W Holland
Journal:  J Clin Microbiol       Date:  1986-03       Impact factor: 5.948

3.  Use of magnesium to increase sensitivity of Limulus amoebocyte lysate for detection of endotoxin.

Authors:  K Tsuji; K A Steindler
Journal:  Appl Environ Microbiol       Date:  1983-04       Impact factor: 4.792

4.  Stimulation of HIV-1-neutralizing antibodies in simian HIV-IIIB-infected macaques.

Authors:  S Müller; D H Margolin; P L Nara; W G Alvord; H Köhler
Journal:  Proc Natl Acad Sci U S A       Date:  1998-01-06       Impact factor: 11.205

5.  Cytosolic Delivery of Argininosuccinate Synthetase Using a Cell-Permeant Miniature Protein.

Authors:  Susan L Knox; Rebecca Wissner; Samantha Piszkiewicz; Alanna Schepartz
Journal:  ACS Cent Sci       Date:  2021-03-18       Impact factor: 14.553

Review 6.  Value of phagocyte function screening for immunotoxicity of nanoparticles in vivo.

Authors:  Eleonore Fröhlich
Journal:  Int J Nanomedicine       Date:  2015-05-26

7.  Development of Germline-Humanized Antibodies Neutralizing Botulinum Neurotoxin A and B.

Authors:  Sebastian Miethe; Christelle Mazuet; Yvonne Liu; Robert Tierney; Christine Rasetti-Escargueil; Arnaud Avril; André Frenzel; Philippe Thullier; Thibaut Pelat; Remi Urbain; Alexandre Fontayne; Dorothea Sesardic; Michael Hust; Michel Robert Popoff
Journal:  PLoS One       Date:  2016-08-25       Impact factor: 3.240

8.  Neutralization of Botulinum Neurotoxin Type E by a Humanized Antibody.

Authors:  Yağmur Derman; Katja Selby; Sebastian Miethe; André Frenzel; Yvonne Liu; Christine Rasetti-Escargueil; Arnaud Avril; Thibaut Pelat; Remi Urbain; Alexandre Fontayne; Philippe Thullier; Dorothea Sesardic; Miia Lindström; Michael Hust; Hannu Korkeala
Journal:  Toxins (Basel)       Date:  2016-09-12       Impact factor: 4.546
  8 in total

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