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LAL, BACTERIAL ENDOTOXIN, AND PYROGEN TESTING -
PHARM/BIOPHARM

LAL Bacterial Endotoxins Test

The LAL (limulus amebocyte lysate) Assay is an in vitro assay used to detect the presence and concentration of bacterial endotoxins in drugs and biological products. Endotoxins, which are a type of pyrogen, are lipopolysaccharides present in the cell walls of gram-negative bacteria. Pyrogens as a class are fever-inducing substances that can be harmful or even fatal if administered to humans above certain concentrations.

Water can be a source of pyrogens, so it may be important to routinely monitor water systems using the bacterial endotoxins test. 

Pacific BioLabs performs the Kinetic Chromogenic LAL Assay, a sensitive colorimetric assay that can detect endotoxin levels in solutions at concentrations as low as 0.005EU/mL. Testing is performed according to USP <85>.

Rabbit Pyrogen Test

The Rabbit Pyrogen Test in an in vivo test to detect pyrogens qualitatively. Rabbits have a similar pyrogen tolerance to humans, so by observing a change in body temperature in rabbits it is possible to make a determination of the presence of pyrogens. This method can detect non-bacterial endotoxin pyrogens as well as bacterial endotoxins.

For more information on LAL testing, visit our Learning Center section on Bacterial Endotoxins Testing.

Available Endotoxin/Pyrogen Test Services

• Kinetic Chromogenic LAL Method (for bacterial endotoxins) - in vitro
  • (10mL sample size required for water; call PBL for containers if needed.)
• USP / JP / EP / ISO (material mediated) Rabbit Pyrogens Test - in vivo