Fact Sheet

BactToxins EP-R - Endotoxin Testing

Interest Group

ATMP manufacturer, pharmaceutical industry, media manufacturer.


The BactToxins EP-C service is performed using fluorogenic recombinant Factor C (rFC) according to EP 2.6.32, an alternative animal free method with no need for Limulus amebocyte lysate (LAL). In addition to this benefit, rFC has low LOT to LOT variability and is not activated by glucan. By default, up to three dilutions of the sample are measured in duplicate, and the assay provides fast and reliable test results.

Recommended Sample Material

Cell cultures, cryo-stocks, sera, antibody formulations, autologous material and many more.


Fluorogenic test method (Endpoint) according to EP 2.6.32 via plate reader.

Applied endotoxin testing system

Pyrogene (Lonza).

Process Control

Controls according to pharmacopoeia (Spike-in, blank, additional control: positive control).

Sample Volume per Assay

90 µl in duplicate per dilution, three dilutions included.

Average Turnaround Time

24 to 48 hours after sample receipt, express testing scheme* possible.

Sensitivity of Method

0.005 EU / ml.

Regulatory Compliance

EP 2.6.32 compliant. Please note, an individual validation is required for LOT / Batch release to demonstrate the efficiency of the analytical procedure in regarding your matrix. Please contact us for further information.

Sample Requirements

Minimum: 600 to 1000 µl
Optimum: 2 units of 600 (to 1000 µl) each, label as sample A and sample B (backup, please mark in accession form).

Order No.

Endotoxin Testing ‘BacToxins EP-R’      47-1003

Volume Discount Available

Yes, on request.

Additional Information

Please note: repetitions which are not caused by our laboratory and *express testing schemes are subject to additonal charges. Please contact us for further information.