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Determination of endotoxin levels

Analysis of endotoxin levels is a crucial part of quality control in biotech, medtech, and pharmaceutical industries. An accurate and precise analysis can help reduce the risk of adverse effects and ensure high quality and safety of biological products.

Purpose

Endotoxins are components of the outer cell membranes in gram-negative bacteria and when released, can cause serious and sometimes deadly inflammatory reactions in humans and animals. Therefore, it is important to ensure that medical devices, biological and pharmaceutical products and materials are free from endotoxins before use.

Method

At RISE, endotoxin levels are analyzed using a kinetic chromogenic Limulus amebocyte lysate (LAL) method according to Eur.Ph.2.6.14 (method D). The LAL test is based on the coagulation reaction of amebocytes from horseshoe crabs, which react with endotoxins. The test is sensitive and specific for endotoxins and can detect very small amounts.

For the analysis, the Endosafe® LAL-cartridge system from Charles River Laboratories, with FDA-licensed cartridges and the Endosafe® Nexgen PTS™ reader is used. The detection limit for the analysis is 0.005 EU/mL.

We can analyze both liquid solutions and solid materials, e.g. medical devices. Solid materials are extracted according to US Pharmacopoeia chapter 161.

Deliveries

The results are presented in a report with an overview of the detected levels in each sample.

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Service

Determination of endotoxin levels in samples

Delivery level

Accredited

Price

Contact us for price information. Please find contact information below.

Preparations

Both solid and liquid samples can be prepared and analysed.

Contact person

Åsa Lindgren

Projektledare

+46 10 516 52 02

Read more about Åsa

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