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Endotoxin Detection

Test for endotoxins is the most critical quality control test required by the FDA for all drugs in the final formulation, because endotoxins are invariably associated with every gram-negative bacteria. In animals and humans, endotoxins elicit strong toxic effects to the organism even present at low concentrations. It is suspected that the endotoxins participate significantly in many different diseases' development and occurrence.
GenScript strongly recommends innovative detection technique for Endotoxin Detection. GenScript Endotoxin Assay Kits can be well
used in in vitro end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices.

Key Feasures:

Good linearity and good reproducibility
Ready-to-use reagents and materials, such as tips, endotoxin-free tubes,etc.
High sensitivity and board application range
Competitive price

Select Your Kit:

Genscript ToxinSensor^TM Chromogenic LAL Endotoxin Assay Kit and ToxinSensor^TM Gel Clot Endotoxin Assay Kit are reliable methods to detect the level of Endotoxin. The procedures in both of these two kits are confirmed with those described in the FDA Guideline.

Chromogenic LAL Assay
Gel Clot Assay
Related Products

ToxinSensor^TM Chromogenic LAL Endotoxin Assay Kit: The kit utilizes a modified Limulus Amebocyte Lysate and a synthetic color producing substrate to quantitatively detect endotoxin chromogenically in a broad range of 0.005 - 1 EU/ml.
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Technical Advantages:

Under the standard conditions, the absorbance at 545 nm is linear in the concentration range of 0.005 to 0.1 or 0.1 to 1 EU/ml endotoxin. Plot the mean Δabsorbance for the four standards on the y-axis vs the corresponding endotoxin concentration in EU/ml on the x-axis. Draw a best fit straight line between these points and determine endotoxin concentrations of samples graphically. See the following figure.

quantification of endotoxin in cheromogenic assay

ToxinSensor^TM Gel Clot Endotoxin Assay Kit: It is a qualitative test for Gram-negative bacterial endotoxin. Limulus Amebocyte Lysate as supplied is to be reconstituted with LAL Reagent Water and then mixed in equal parts with the solution being tested. After incubation, and in the presence of endotoxin, gelation occurs; in the absence of endotoxin, gelation does not occur.
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Technical Advantages:

Sample: Protein A, 1 mg/ml in PBS, pH 7.4. It is purified from E. coli sonicate by Ni-NTA resin.
Dilution by LAL water: 1: 200,000, 1: 400,000, 1: 800,000
The test is performed as described above and the assay result is:

Positive control	Negative control	1: 200,000	1: 400,000	1: 800,000
+	-	+	-	-

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