Conventional Test Method:

Rabbit Pyrogen Test (RPT) (USP 151)

Alternative Test Method:

MM6 IL - 6 In Vitro Pyrogen Test

This test is based on the principle that white blood cell monocytes differentiate into macrophages and release inflammatory cytokines when exposed to bacterial endotoxin. The test exposes human monocytoid cell line to the test substance and measures cytokine release (IL-6) using an immunoassay.

Validation Status:

EU: Validated by ECVAM for the detection of pyrogenicity mediated by Gram-negative endotoxin (2006)

US: Found suitable by ICCVAM for use to detect Gram-negative endotoxin in human parenteral drugs on a case-by-case basis, subject to validation for each specific product to demonstrate equivalence to the RPT (2008)

Regulatory Status:

No information

Effect or Potential Effect on Animal Use:

Replacement
(when used to test for Gram-negative endotoxins)

References:
Information Last Reviewed:
May 2012