Determination of Bacterial Endotoxin (LAL)

What is Bacterial Endotoxin (LAL) Determination? Which Products Should Be Tested?

Endotoxin; It can be expressed as a component of the outer membrane of gram negative bacterial cells. In short, it is a lipopolysaccharide found in the cell wall of gram negative bacteria.

It is found in environments where gram-negative bacteria live, such as water and air, and even if the bacteria die. Around 10 ^-12 - 10 ^-9 g, even if it enters the body, it is a pyrogen that causes various biological reactions.

Pyrogenic substances are harmful substances that cause high fever, which can be produced by positive bacteria, mycobacteria, fungi, as well as viruses. However, pyrogens produced by gram negative bacteria are especially important for the pharmaceutical industry.

Good examples of pyrogen-producing gram-negative bacteria are Escherichia coli, Proteus, Pseudomonas, Enterobacter and Klebsiella.

Determination of bacterial endotoxin, namely LAL, is the determination of the toxic structures of gram negative bacteria in the cell walls.

On Which Products Is LAL Determination Performed?

- In vitro medical products (products that come into direct or indirect contact with cardiovascular, lymphatic or cerebrospinal fluid such as pacemakers and prostheses) Injectable pharmaceutical products in the pharmaceutical industry
- In dialysis waters

Bacterial Endotoxin Test Standards:

- European Pharmacopeiae (E.P.) 2.6.14-Bacterial Endotoxins
- United States Pharmacopeiae (USP) -85-Bacterial Endotoxins Test

CLICK FOR MEDICAL PRODUCT ANALYSIS.