The LAL test is the most sensitive and specific means to detect and measure endotoxin, a fever-producing by-product of gram-negative bacteria commonly known as pyrogen. readily recognized. The USP Bacterial Endotoxins Test and U.S. Food and Drug Administration Guideline for LAL testing provide standard methods for validating the LAL Test as a replacement for the rabbit pyrogen test.
Charles River Singapore is the first laboratory in Singapore to be ISO 17025 accredited for the full panel of LAL Bacterial Endotoxin Tests using the LAL Gel clot method, kinetic turbidimetric and kinetic chromogenic methods (according to USP, BP, EP and JP specifications). We have extensive experience in testing various raw materials, sub-assemblies, process materials (e.g. water) as well as end-product active pharmaceutical ingredients, medical devices and biologics. Charles River Singapore uses the Charles River Endosafe® brand of bacterial endotoxin test reagents for all our in-house tests.
|
Test Code |
Description |
|
LGC-002 |
LAL Gel Clot Method, semi-quantitative (routine) |
|
LKT-002 |
LAL Kinetic Turbidimetric, quantitative (routine) |
|
LKC-002 |
LAL Kinetic Chromogenic, quantitative (routine) |
|
IET * |
Inhibition and Enhancement Screening; Method Development and Validation |
*Inhibition and enhancement screening detects potential interferences to the LAL Bacterial Endotoxin Tests. It is an FDA requirement that the inhibition and enhancement properties of a product are addressed and overcome in the validation of the routine LAL test for final release testing.
Conduct Bacterial Endotoxin Testing in-house!
Through the wide range of Charles River Endosafe®products and solutions, Charles River SIngapore is able to help you develop endotoxin test capabilities in-house for LAL gel clot, kinetic turbidimetric and kinetic chromogenic methods, as well as the PTS™and MCS™ the revolutionary on-line endotoxin test systems from Charles River.
Ask our This email address is being protected from spambots. You need JavaScript enabled to view it. about our In-house Bacterial Endotoxin Test Qualifying Package.
Our basic package includes:
- Protocol development
- Method development and validation
- IQOQPQ of microplate readers or PTS™/ MCS™ systems
- Analyst qualification
- LAL Bacterial Endotoxin Test seminar and hands-on training