FDA-licensed LAL Reagents

Limulus amebocyte lysate (LAL) is an aqueous extract of blood cells (amebocytes) from the Atlantic horseshoe crab, Limulus polyphemus. Comprised of proteins, LAL is used to detect the presence of endotoxins, a cell wall component of Gram-negative bacteria that causes a pyrogenic response (fever) and symptoms of septic shock. Even if dead, these components trigger a response in LAL, causing it to clot and coagulate.

Kinetic Turbimetric LAL Reagent

Charles River Endosafe two kinetic turbidimetric LAL endotoxin test reagents, KTA and KTA2, yield quantitative endotoxin values when used with a microplate reader equipped with endotoxin-measuring software. Both reagents are buffered to provide significant interference-resistance properties and are FDA-licensed for use in product release testing. Our kinetic turbidimetric endotoxin test reagents are buffered to give the best interference-resistance properties.

Charles River Endosafe traditional kinetic turbidimetric assay reagent (KTA) is suitable for both kinetic and gel-clot analyses and permits a direct correlation between LAL methods.

Charles River Endosafe second-generation reagent KTA2 offers one of the fastest turbidimetric LAL reaction times on the market, and our optimized formulations offer an unrivaled combination of sensitivity, linearity, and interference resistance properties with minimal assay times. Its superior turbidimetric formulation offers the performance of a kinetic chromogenic LAL test at the price of a turbidimetric reagent.

Kinetic Turbimetric LAL Reagents Product Codes
Product Sensitivity Product Code
KTA
50-Test Vial (5.2 mL)
0.015 EU/mL R15015
0.03 EU/mL R15003
0.06 EU/mL R15006
KTA2
50-Test Vial (5.2 mL)
0.005 EU/ml R19000

Gel-Clot Endotoxin Test Reagents

The gel-clot assay determines the presence of endotoxins through its clotting response, and is a quick and effective way to detect harmful endotoxins for your injectable pharmaceuticals. Endosafe® Rapid LAL Single-Test Vials contain FDA-licensed LAL to provide a simple, self-contained option for routine endotoxin detection in research samples, renal dialysis process water, and dialysate solutions.

Accurate gel-clot assay results ensure the safety of your pharmaceuticals. The gel-clot endotoxin test is a simple qualitative method best used for low-volume laboratories or for products such as those that are highly viscous or extremely colorful. Our gel-clot endotoxin test lysate features a firm gel over a wide range of sensitivities as the buffered reagent provides better interference resistance and higher accuracy for routine LAL testing. Find out if gel-clot is the best method for your lab.

Gel-Clot LAL Reagents Product Codes
Product Sensitivity EU/mL Code
50-test vial (5.2 mL) 0.015 R15015
0.03 R15003
0.06 R15006
0.125 R11012
0.25 R11025
10-test vial (1.2 mL) 0.03 R12003
0.06 R12006
0.125 R12012
0.25 R12025

Traditional LAL Kinetic Chromogenic Assay

Endochrome-K™, our traditional LAL kinetic chromogenic assay (KCA) facilitates your endotoxin screening with its ease of use and unique reagent stability. Featuring an optimized 0.005 EU/mL sensitivity*, our traditional kinetic chromogenic assay reagent provides heightened sensitivity for more accurate results, greater linearity for endotoxin analyses, and superior interference resistance. Our traditional LAL kinetic chromogenic reagent is designed to enhance your kinetic chromogenic assay and rapidly deliver accurate results.

Endosafe® Kinetic Chromogenic LAL Reagents
Product Code
Endochrome-K™ kit - 256 tests
(sensitivity= 50-0.005 EU/ml)
8 X3.2 mL vials
2 X 10 ng control standard endotoxin
3 X 30 mL LAL reagent water
R1708K
Endochrome-K™ 
(sensitivity= 50-0.005 EU/ml)
3.2 mL vials x100
R1700
Endochrome-K™ 
(sensitivity= 50-0.005 EU/ml)
3.2 mL vials x10
R1710K
Endpoint chromogenic kit (140 tests)
5 X 1.4 mL vials of chromogenic LAL
1 X 10 mg vial of chromogenic substrate S-2423
2 X 2 ng vials of endotoxin
2 X 30 mL vials of LAL reagent water
1 X 15 mL 0.05 M vial of Tris buffer
R160K

LAL Assay Accessories

Charles River provides all the necessary endotoxin-free test tubes and accessory products required to run an LAL assay. All accessory products are provided with a certificate of quality certifying appropriate endotoxin levels. These high-quality accessories impart control and consistency to LAL assays and the LAL laboratory, thereby minimizing invalid results and repeat testing. A critical part of running a LAL assay is the choice of endotoxin-free test tubes and accessories that enable data collection free of artifacts and sources of interference. The selection of non-interfering LAL assay accessories for a bacterial endotoxin test is not only a pharmacopeial directive, but also a regulatory expectation. Accessories play a major role in the quality of results generated in the BET lab.

Control Standard Endotoxin and Reference Standard Endotoxin
Product Packaging Code
CSE – 500 ng per vial* 6/pack E110
CSE – 10 ng per vial* 6/pack E120
Positive control (for single test) 25/pack PC100
Reference standard endotoxin (RSE)   E150
Extended CSE (CXE) Dilution Kit*
1 × 10 ng CSE
1 × 60 mL stabilizing solution
1 pack of 11 of 16 × 100 mm capped tubes
  E140
LAL Reagent Water
Product Packaging Code
30 mL bottle (< 0.001 EU/mL) 12/case W130
50 mL bottle (< 0.001 EU/mL) 12/case W120
100 mL bottle (< 0.001 EU/mL) 12/case W110
500 mL bottle (< 0.001 EU/mL) 6/pack W150
LAL Buffers
Product Packaging Code
5 mL 0.25 M Tris buffer 6/pack BT101
30 mL 0.1 M Tris buffer 12/case BT103
5.5 mL 0.1 M Tris buffer 6/pack BT105
30 mL 0.05 M Tris buffer 12/case BT106
4 mL 0.5 M MgSO4, 1 M Tris buffer 6/pack BC1000
30 mL bio-dispersing agent 12/case BD100
Endotoxin-Specific (ES) Buffer 6/pack BG200
Endotoxin Indicators
Product Code
10,000 EU EVV10K
100,000 EU EVV100K
1 Million EU EVV1M
2.5 Million EU EVV2.5M
10 Million EU EVV10M
Reaction Tubes
Product Packaging Code
10 × 75 mm capped flint glass tubes, boxed 50/pack T100
10 × 75 mm flint glass tubes, in foil 50/pack T200
10 × 75 mm borosilicate glass tubes, in foil
(appropriate for use with tube readers)
50/pack T400
8 × 75 mm borosilicate glass tubes, in foil
(only for use with tube readers)
50/pack T500
10 × 75 mm screw-cap borosilicate glass tubes, boxed 70/pack TL1200
Tubes
Product Packaging Code
12 × 75 mm borosilicate glass tubes, in foil 50/pack TL1000
13 × 100 mm borosilicate glass tubes, in foil 50/pack T300
16 × 90 mm screw-cap borosilicate glass tubes, boxed 70/pack TL700
18 × 150 mm borosilicate glass tubes, in foil 14/pack T600
Depyrogenated Glass Pipettes
Product Packaging Code
1 mL, in foil 5 packs P100
2 mL, in foil 5 packs P200
5 mL, in foil 5 packs P500
10 mL, in foil 5 packs P1000
Eppendorf® Pipette Tips
Product Packaging Code
Eppendorf® pipette tips (2-200 μL,* individually wrapped) 50/pack D100EA
Eppendorf® pipette tips (2-200 μL,* individually wrapped) 100/pack D200
96-Well Endosafe® Plates (individually wrapped)
Product Code
96-well polystyrene plate (certified to 0.005 EU/mL) M9005
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