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

  • Regulatory status:RUO
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New 890031 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.

The rapid GO version of EndoZyme® II features GOPLATE™ - a microplate pre-filled with dried Control Standard Endotoxin, standard curve 0.005 - 50 EU/ml and Positive Product Controls (PPC) 0.5 EU/ml, all in duplicate replicates fulfilling pharmacopoeia standard curve requirements.

This new version of EndoZyme® enables endotoxin testing in pharmaceutical grade water, injectable drugs and other pharmaceutical products. EndoZyme® II GO allows an easy and fast workflow, and is particularly adapted to raw materials and final product 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.

EndoZyme® II GO Benefits:

  • Assay run time: 20 minutes (0.05 EU/ml), 60 minutes (0.005 EU/ml)
  • Preloaded microplate eliminates manual preparation of standard dilutions and PPCs
  • Over 50% reduction in handling time compared to conventional microplate assays
  • Significantly reduces risk of handling error during preparation steps
  • Higher precision and rate of valid results
  • Ideal for in-process control of water and raw materials, as well as product release testing
  • Ideal for automation and parallel processing of plates

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.

The rapid GO version of EndoZyme® II features GOPLATE™ - a microplate pre-filled with dried Control Standard Endotoxin, standard curve 0.005 - 50 EU/ml and Positive Product Controls (PPC) 0.5 EU/ml, all in duplicate replicates fulfilling pharmacopoeia standard curve requirements.

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