PBL Logo - click here to return to homepage spacer

spcr
 
 

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

LAL and Bacterial Endotoxins Testing

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, and is an important part of pharmaceutical microbiology. 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.

The endotoxin testing lab at 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.

In addition to pharmaceutical preparations, water can also be a source of pyrogens. Therefore, it may be important to perform endotoxin testing to routinely monitor water systems.

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.

Available Endotoxin and Pyrogen Testing 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

LAL Endotoxin and Rabbit Pyrogen Testing Standards

LAL Endotoxin and Rabbit Pyrogen Related Testing

Read More About LAL Endotoxin and Rabbit Pyrogen Testing

 

 
 
 
Intertek Logo PBL is FDA registered and ISO 9001:2008 and ISO 13485:2003 certified by Intertek. AAALAC Logo Our animal science operations are accredited by AAALAC.
   
   

Request a quote Send an email