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ENDONEXT™ EndoZyme® II – Recombinant Factor C (rFC) Endotoxin Detection Assay

  • Regulatory status:RUO
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Cat. No. Size Price


New 890030 192 Tests
Product Details
Technical Data

Description

The ENDONEXT™ EndoZyme® II assay is the enhanced second generation of EndoZyme®, based on recombinant Factor C (rFC), the synthetic analogue to the native endotoxin-specific principal receptor in the Limulus Amebocyte Lysate (LAL) cascade. Instead of being based on an animal source, EndoZyme® II is a sustainable alternative method in line with regulatory requirements. EndoZyme® II is particularly suited for end-product testing and in-process control of water and raw materials, as well as medical device testing.

Shipping

At ambient temperature. Upon receipt, store the product at the temperature recommended below.

Storage/Expiration

Unopened kits are stable at 2–8°C until the expiry date printed on the label.

Calibration Range

0.005 – 50 EU/ml

Limit of Detection

0.005 EU/mL

Summary

Features

EndoZyme® II Features:

  • Horseshoe Crab-free method relying on sustainable resources
  • State-of-the-art sensitivity (0.005 EU/ml) and assay range
  • Endotoxin-specific, no false-positive results from β-Glucans
  • Excellent lot-to-lot reproducibility
  • Stable liquid reagents enabling flexibility in use
  • Follows BET methodology and validated according to the same criteria as conventional methods
  • Accepted by the FDA and included in the European Pharmacopoeia Chapter 5.1.10 since 2016.

Summary

ENDONEXT™ EndoZyme® II is a fluorescence end-point assay intended for quantitative determination of endotoxin (chemically lipopolysaccharide, LPS) in pharmaceutical end-products, in-process control and research samples, and medical device testing.

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