Bacterial Endotoxin Testing

Bacterial endotoxins are heat-stable, amphiphilic lipopolysaccharides (LPS) found in the outer membrane of Gram-negative bacteria. They are released when the bacteria are killed or undergo cell lysis. Bacterial endotoxins can cause a strong immune response in humans and animals and trigger a variety of negative effect, including fever, shock, and even death. Hence, testing for bacterial endotoxins is essential to ensure the safety and efficacy of pharmaceuticals, medical devices, and other products. Moreover, manufacturers can identify and eliminate contamination before the product reaches the market by this testing, thus protecting the health of consumers and ensuring compliance with regulatory requirements. At Alfa Chemistry, we offer a comprehensive bacterial endotoxin testing service and our experienced team of scientists uses state-of-the-art equipment to detect and quantify endotoxin contamination in a variety of sample types.

Alfa Chemistry offers bacterial endotoxin testing for:

We offer a range of testing methods for bacterial endotoxins, including:

Limulus Amebocyte Lysate (LAL): This sensitive and specific test uses the blood of the horseshoe crab to detect the presence of endotoxins in a sample. At Alfa Chemistry, three types of LAL methods are used:

• Kinetic Chromogenic: This method involves adding a substrate that changes color in the presence of endotoxins to the LAL reagent. The rate of color change is proportional to the concentration of endotoxins in the sample, allowing for quantitative measurement.
• Gel Clot assay: This method involves adding the LAL reagent to the sample and observing for the formation of a gel clot. The time it takes for a gel clot to form is recorded and used to determine the endotoxin concentration in the sample.
• Kinetic Turbidimetric: This method involves measuring the change in turbidity of the sample as endotoxins interact with the LAL reagent. This method is commonly used for samples with high levels of endotoxins.

Recombinant Cascade Reagent (rCR): Recombinant Cascade Reagent (rCR) is a synthetic reagent that can be used in bacterial endotoxins testing as an alternative to traditional Limulus Amebocyte Lysate (LAL) reagents. rCR is a recombinant form of Factor C, a key enzyme in the LAL pathway that can react with bacterial endotoxins, triggering a cascade of events that can lead to the detection of endotoxins.

Applicable standards include:

Alfa Chemistry's advantages: