article

Expert view: The right endotoxin detection solution for you – bioMérieux’s complete portfolio of rFC endotoxin assays

Posted: 19 October 2020 | | No comments yet

As part of any general pyrogen testing strategy, the detection of even minute traces of the highly pyrogenic bacterial molecule called lipopolysaccharide (LPS, also named endotoxin) in pharmaceutical samples is mandatory to ensure patient safety.

Therefore, endotoxin testing has been tightly regulated by international pharmacopoeias, such as the United States Pharmacopoeia (USP; chapter <85>), the European Pharmacopoeia (EP; chapter 2.6.14) or the Japanese Pharmacopoeia (JP; chapter 4.01) with the Limulus Amebocyte Lysate assay (LAL) set as standard. As of 1 January 2021, a mandatory full validation of the current alternative method recombinant Factor C (rFC; according to USP <1225>) will become obsolete with the publication of the new general chapter 2.6.32 in the 11th edition of the EP with other pharmacopoeia in the pipeline.

    To read this expert view in full, please complete the form below:

     









    This specialist content is provided to you free-of-charge thanks to the kind support of bioMérieux

    By clicking submit you confirm that you accept our terms and conditions and privacy policy.

    Related topics

    , ,

    Related organisations