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Endotoxin Analyses

Endotoxin detection and quantification

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Endotoxin analyses are performed to detect or quantify endotoxins from gram-negative bacteria. We perform the analyses in accordance with Ph Eur 2.6.14 / USP with a sensitivity down to 0,001 EU/ml.

Before analysing a product in routine an Interfering Factor Test (IFT) is performed. This test verifies the method of choice by pointing out possible inhibitory or enhancing properties of the product. The validation includes testing of different concentrations/dilutions of the product in order to set the detection limit below the specification limit, also called Maximum Valid Dilution (MVD). The validation is described in Ph Eur 5.1.10 “Guidelines for using the test for bacterial endotoxins” and USP .

The principle of the method is a coagulase reaction between the endotoxin from gram-negative bacteria and Limulus lysate. The analysis is performed with endotoxin-free water and consumables. In parallel to each test, a negative control is included and a standard curve is generated for correct quantification.

We perform endotoxin analysis using the three methods below:

Gel-ClotGel-Clot method: A semi-quantitative method based on the visual appearance of a gel formation in the test tube. The sensitivity of this method is 0,03 EU/ml.

Kinetic Turbidimetric Technique: Spectrophotometric determination of a gel formation with a sensitivity down to 0,01 EU/ml. This method is suitable for coloured samples which cannot be analysed with the Chromogenic method but are less suitable for turbid samples.

Kinetic Chromogenic Technique: The most sensitive method and the first quantitative method to be developed. Depending of what lysate that is used, the sensitivity ranges from 0,005 to 0,001 EU/ml. The method is based on coloration due to the generation of a chromogenic complex between the endotoxin and the lysate. The method is less suitable for coloured samples but can be used for turbid samples.

Analysis result, response time

Response time is dependent on sample characteristics but normal time requirement from sample arrival to analysis report-out are 5 business days. For more information, see general terms and conditions