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  • Bacterial Endotoxin Assay Kit
ORIGIN OF ENDOTOXIN

Harmonized Gel-Clot Limit Method for Testing of Bacterial Endotoxin as per USP, EP, JP and ICH Guidelines

POTENTIAL USER SEGMENTS :

  • Pharmaceuticals
  • Vaccines
  • Biologicals
  • Hospitals
  • Medical Device Manufacturers

ADVANTAGES :

  • Single-test format available for all lysate sensitivities
  • Ampoule packing reduces need for pyrogen free tubes as well as reconstituting lysate.
  • Simply add your sample, mix and incubate!
  • Highly stable Control Standard Endotoxin (CSE) provided with the kit
  • Cost effective premium quality reagents compared to those of competitors

INTENDED USE :

  • Qualitative detection of endotoxin
  • Pyrogen control or endotoxin detection during production processes

PRINCIPLE :

  • Presence of the endotoxin activates factor C in the horseshoe crab amoebocyte lysate
  • Activated factor C further activates factor B
  • Pre-clotting enzyme (inactive) is cleaved by activated factor B into clotting enzyme (active)
  • Active enzyme reduces Coagulogen into Coagulin thereby leading to clot formation
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