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Bacterial Endotoxins Test

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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

Gel-clot Method

  • Lysate reagent (labeled sensitivity λ)
    PYROGENTTM Plus (λ = 0.06 EU/mL) (Lonza)
    LAL ES-II (λ = 0.015 EU/mL) (FUJIFILM Wako)