Abstract
The current status of the Limulus Amebocyte Lysate (LAL) test for final release of drug products and devices in the United States and abroad is discussed. The principal problem dealt with is determining an endotoxin limit for the LAL assay. This is significant because the LAL test is more sensitive than the USP rabbit pyrogen test, and because, as comparative LAL and rabbit assays indicate, purified endotoxin standard is more pyrogenic than environmental endotoxin.
- Received September 9, 1983.
- Accepted November 20, 1983.
- Copyright © Parenteral Drug Association. All rights reserved.
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