Bacterial Endotoxins Test
We develop and validate methods for testing bacterial endotoxins in compliance with general tests in Pharmacopoeia (JP <4.01>, USP <85>, EP 2.6.14). Bacterial endotoxins are controlled not only in finished products (injectable) but also in APIs, excipients, and process solutions.
Bacterial endotoxins test can be conducted using three methods, “gel-clot,” “chromogenic,” and “turbid metric.” We primarily use the kinetic chromogenic method and the gel-clot method.
Kinetic Chromogenic Method
- Lysate reagent: Kinetic-QCL (Lonza)
- Range of standard curve: 0.01 – 1 EU/mL
- Lysate reagent (labeled sensitivity λ)
PYROGENTTM Plus (λ = 0.06 EU/mL) (Lonza)
LAL ES-II (λ = 0.015 EU/mL) (FUJIFILM Wako)