Endotoxin Contamination of Parenteral Drugs and Radiopharmaceuticals as Determined by the Limulus Amebocyte Lysate Method
1984
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.
Keywords:
- Correction
- Source
- Cite
- Save
- Machine Reading By IdeaReader
0
References
26
Citations
NaN
KQI