Endotoxin contamination of parenteral drugs and radiopharmaceuticals as determined by the limulus amebocyte lysate method

CW Twohy, AP Duran, TE Munson - PDA Journal of Pharmaceutical …, 1984 - journal.pda.org
From January 1980 to October 1983, the Food and Drug Administration (FDA) examined
2526 samples, including 333 different drug products, by the limulus amebocyte lysate (LAL) …

Application of LAL for detection of endotoxin in antibiotic preparations.

SJ Harrison, K Tsuji, RM Enzinger - Progress in Clinical and …, 1979 - europepmc.org
The Limulus amebocyte lysate (LAL) test has been investigated as an alternative method to
the USP pyrogen test for the detection of endotoxin contamination in these antibiotic …

Detection of endotoxin in biological products by the limulus test.

JF Cooper, SM Pearson - Developments In Biological …, 1977 - europepmc.org
The limulus amebocyte lysate (LAL) test is established as a beneficial quality assurance
measure for the parenteral drug industry because of its sensitivity, specificity, and simplicity …

Guideline for validation of the LAL test as an end-product endotoxin test for human and biological drug products.

TE Munson - Progress in clinical and biological research, 1985 - europepmc.org
The draft guideline sets forth acceptable conditions for use of the Limulus Amebocyte Lysate
(LAL) test. It also describes procedures for using this methodology as an end-product …

Quantitative comparison of in vitro and in vivo methods for the detection of endotoxin

JF Cooper, J Levin, HN Wagner - The Journal of laboratory and …, 1971 - translationalres.com
The administration of drugs or fluids which have become contaminated with bacterial
endotoxin can produce shock, fever, and death. The current legally required bioassay for …

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

K Tsuji, KA Steindler, SJ Harrison - Applied and Environmental …, 1980 - Am Soc Microbiol
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 …

[CITATION][C] Penicillins and the limulus amoebocyte lysate test for endotoxin

PM Newsome - Journal of Pharmacy and Pharmacology, 1977 - Wiley Online Library
The use of the limulus amoebocyte lysate test for the detection of pyrogens has recently
been reviewed by Cooper (1975). Eibert (1972) reported that 84 samples of injectable drugs …

Endotoxin Detection in Pharmaceuticals and Medical Devices with Kinetic-QCL a Kinetic-Quantitative Chromogenic Limulus Amebocyte Lysate Assay

RN Berzofsky - ALTEX-Alternatives to animal experimentation, 1995 - altex.org
The observation that endotoxin caused gelation in extracts of Limulus amebocytes has been
expanded to the development of an in vitro kinetic, quantitative chromogenic LAL assay …

The significance of Limulus amebocyte lysate test specificity on the pyrogen evaluation of parenteral drugs

FC Pearson, M Weary - PDA Journal of Pharmaceutical Science …, 1980 - journal.pda.org
Although the sensitivity of the Limulus Amebocyte Lysate (LAL) Test for gram-negative
endotoxin is well established, several reports have appeared in the literature indicating that …

Comparison of several control standard endotoxins to the National Reference Standard Endotoxin--an HIMA collaborative study

FC Pearson, ME Weary, HE Sargent… - Applied and …, 1985 - Am Soc Microbiol
A collaborative study, initiated under the auspices of the Health Industry Manufacturers
Association (HIMA), was designed to establish the relationship of Escherichia coli O55: B5 …