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.
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