BioLASCO Taiwan Co., Ltd.
3F., No. 267, Chongyang Rd., Nangang Dist., Taipei City, , Taiwan (R.O.C.)
Tel:(02) 2651-8669
Fax:(02) 2651 – 8969
Gel-clot Endotoxin Test
Limulus amebocyte lysate (LAL), an aqueous extract derived from Limulus amebocytes, which is intended for quantitative detection of endotoxins by the Gel-clot methods. Improvements in LAL reagents, the advent of standard methods and automated systems, and a better understanding of LAL reactivity make the LAL reagent readily adaptable to testing a variety of biologics, parenteral products and medical devices. Currently, endotoxin detection methods based on lysate reagents include the Gel-Clot, Turbidimetric assay, and Chromogenic assay.
CRL Endosafe® endotoxin testing reagent has been approved by the FDA. Our gel clot endotoxin test lysate features a firm gel over a wide range of sensitivities, designed with advanced formulations to provide better interference resistance and higher accuracy for routine LAL testing.
Gel-Clot Reagents
As the original BET method of testing, a gel-clot endotoxin test is one of the simple assays that can be conducted that yields qualitative results indicating the presence of endotoxins. This is determined through a clotting response and is a quick and effective way to detect harmful endotoxins for your injectable pharmaceuticals. A positive response on the Gel-clot test indicates that there is an amount of endotoxin in the sample which equals or exceeds the reagent’s labelled sensitivity, represented by the symbol lambda, λ.
| Gel-Clot | Sensitivity (EU/mL) | Code | Format |
| 50-test vial (5.2 mL) | 0.015 | R15015 | Box of 100 Pack of 6 |
| 0.03 | R15003 | ||
| 0.06 | R15006 | ||
| 0.125 | R11012 | ||
| 0.25 | R11025 |
Control Standard
The E. coli CSE is a validated positive control, standardized and quantified using the U.S. Reference Standard Endotoxin. For detailed verification, please refer to the Certificate of Analysis (CoA).
| Control Standard Endotoxin | Code | Format |
| CSE-10 ng per vial | E120 | Pack of 6 |
| CSE-500 ng per vial | E110 | Pack of 6 |
| Reference standard endotoxin (RSE) | E150 | ─ |
LAL Reagent Water
To prevent contamination, all accessories and consumables must be endotoxin-free. Reagents and test samples should be prepared using endotoxin-free water for bacterial endotoxin testing.
| LAL Reagent Water | Code | Format |
| 50 mL bottle | W120 | Case of 12 |
| 100 mL bottle | W110 | Case of 12 |
| 500 mL bottle | W150 | Pack of 6 |
* Endotoxin Test Result : < 0.001 EU/mL.