Endotoxin contamination of parenteral drugs and radiopharmaceuticals as determined by the limulus amebocyte lysate method
Twohy, C.W.; Duran, A.P.; Munson, T.E.
Journal of Parenteral Science and Technology a Publication of the Parenteral Drug Association 38(5): 190-201
1984
ISSN/ISBN: 0279-7976 PMID: 6512657 Document Number: 425
From Jan. 1980-Oct. 1983, the USA Food and Drug Administration (FDA) examined 2526 samples, including 333 different drug products, by the Limulus amoebocyte lysate (LAL) method. Of the drug products tested, 99 showed no product inhibition and 236 required some dilution to overcome inhibition. Compatible endpoints of 20 drug products varied by > 1 two-fold dilution; 14 were inhibitory at the maximum valid dilution and unsuitable for this analysis. Of the total samples tested, 77 (3.05%) contained various amounts of endotoxin and 15 of these failed the proposed FDA limit. The LAL test was found to be extremely useful for detecting and quantifying bacterial endotoxins in a wide variety of parenteral products.
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