rFC mimics the natural Factor C found in horseshoe crab blood, binds specifically to endotoxin, which triggers a cascade reaction resulting in a measurable signal.
Bacterial Endotoxin Testing
Endotoxin detection tests check the safety, namely absence of endotoxins, in sterile pharmaceutical products for human consumption. In addition, the detection of endotoxins in non-sterile products, as well as in the analysis of pharmaceutical water plays an important role.
The detection of bacterial endotoxins, which originates from gram-negative bacteria, is mainly carried out using amoevocyte lysate (LAL), which is obtained from horseshoe crab blood (Limulus polyphemus or Tachypleus tridentatus). The corresponding chapters have been harmonised between the European Pharmacopoeia ((Ph. Eur.) 2.6.14.), the United States Pharmacopoeia ((USP) <85>) and the Japanese Pharmacopoeia ((JP) 4.01). Endotoxins are toxic to humans and/or animals and cause a pyrogenic reaction (increase in body temperature). For this reason, it is important that bio/pharmaceuticals are tested for endotoxin content.
Tests
Traditional Limulus Amebocyte Lysate (LAL) Methods
