Abstract
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 substances other than endotoxin can elicit positive LAL test reactions under certain conditions. This discussion of LAL test specificity deals with the impact these findings could have on the use of LAL for pyrogen testing in the parenteral drug industry, and concludes that false positive LAL test reactions due to substances other than endotoxin need not concern most parenteral drug manufacturers. These, however, can be ruled out by using appropriate controls.
- Received August 1, 1979.
- Accepted November 28, 1979.
- Copyright © Parenteral Drug Association. All rights reserved.
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