RT Journal Article
SR Electronic
T1 Endotoxin Contamination of Parenteral Drugs and Radiopharmaceuticals as Determined by the Limulus Amebocyte Lysate Method
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 190
OP 201
VO 38
IS 5
A1 Christine W. Twohy
A1 Anthony P. Duran
A1 Terry E. Munson
YR 1984
UL http://journal.pda.org/content/38/5/190.abstract
AB 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) 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 more than one twofold 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 (K/M). The LAL test was found to be extremely useful for detecting and quantifying bacterial endotoxins in a wide variety of parenteral products.