Limulus Amebocyte Lysate (LAL) Endotoxin Detection Assays

Limulus amebocyte lysate (LAL) is an aqueous extract of blood cells (amoebocytes) from the Atlantic horseshoe crab Limulus polyphemus. LAL reagents are primarily used to test for endotoxins in injectable pharmaceuticals, biological products, and medical devices. They are also used in renal dialysis centers and a wide range of other applications. LAL tests are described in the Bacterial Endotoxins Test chapter in the United States Pharmacopeia (Chapter <85>) and in the equivalent chapters in the European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01).

How does a LAL test work?

LAL reacts with bacterial endotoxin lipopolysaccharide (LPS), which is a membrane component of gram-negative bacteria. This reaction is the basis of the LAL test, which is widely used for the detection and quantification of bacterial endotoxins.

What kinds of LAL tests are there?

There are three main types of quantitative LAL tests that are widely used for BET:

  • chromogenic
  • turbidimetric
  • recombinant technologies

These assays can not only determine the presence/absence of endotoxin in a sample, but also reveal the quantity of endotoxin present. This data facilitates compliance to quality control (QC) testing and data integrity standards for a wide range of applications in pharmaceutical drug development and manufacturing.

CompanyACCACCACCACC
ItemPyrotell Gel-clot FormulationPyrochrome Kinetic Chromogenic Endotoxin Testing ReagentsPyrosate Kit Rapid Endotoxin DetectionPyrotell-T Turbidimetric Formulation
Price
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DescriptionProduct Description

Pyrotell® lysate was the first LAL gel-clot reagent licensed by the US FDA. It is easy to use and is available in both economical multi-test vials and convenient Single Test Vials (STV’s). Pyrotell lysate is a robust reagent,

Pyrochrome is a versatile quantitative reagent that is used to perform kinetic or endpoint assays. It is a sensitive and flexible reagent that can be used for testing in compliance with the USP, EP and JP bacterial endotoxins test chapter. Pyrochrome

Product Description

The Pyrosate kit offers some unique advantages over standard LAL gel-glot testing methods. The assay does not require special training or laboratory supplies. The step-by-step illustrated instructions allow the user to perform

Product Description

Pyrotell®-T lysate is used to quantify endotoxin in kinetic turbidimetric tests. Pyrotell-T lysate can be used with the Pyros Kinetix® tube reader and also incubating microplate readers. When used with the Pyros Kinetix

MethodLALLALLALLAL
SensitivityPyrotell is available in a variety of sensitivities: 0.03 EU/mL; 0.06 EU/mL; 0.125 EU/mL; and 0.25 EU/mL.maximum sensitivity of 0.001 EU/mL0.25 EU/mL and 1.0 EU/mL0.001 EU/mL.
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