Conventional Test Method:

Rabbit Pyrogen Test (RPT) (USP 151)

Alternative Test Method:

Name & Description:

Limulus Amebocyte Lysate (LAL) Test a.k.a. Bacterial Endotoxin Test

This test uses blood from Horseshoe crabs (Limulus polyphenus) which is very sensitive to bacterial endotoxin and coagulates in its presence. Limulus amebocyte lysate (LAL) is incubated with test substance and in some cases, other substrates which aid in endotoxin detection or quantification. Several recognized techniques exist, including gel-clot methods, chromogenic methods and turbidimetric methods.

Validation Status:

EU/US/Japan: To use test for regulatory purposes; an “in-house” validation program is required 

Regulatory Status:

EU: Accepted by EU and listed in the EDQM/European Pharmacopeia (5.0)

US: Accepted by the FDA and listed in the United States Pharmacopeia (USP 85)

Japan: Listed in Japanese Pharmacopeia XIV

Effect or Potential Effect on Animal Use:

Replacement
(Relative replacement: replacing more sentient animals with animals that current scientific peer advice and interpretation of scientific evidence indicate have a lower potential for pain perception)

References:
Information Last Reviewed:
May 2012