Products
Host Cell Residue Detection
Process Impurity Assay
Advnetitious Agent/Microorganism Testing
Pyrogen / Endotoxin Detection
Genetic Stability
Cell Line Characterization
Viral Titer Assay
Detection Equipment
Biochemical Reagents
Recombinant Cascade Reagent (rCR)
The bacterial endotoxin test (BET) is a critical part of pharmaceutical quality control (QC), as endotoxins can trigger severe immune responses in humans and animals even at trace levels. Traditional testing relies on Limulus amebocyte lysate (LAL), which impacts natural resources while also presenting challenges such as cross-reactivity and lot-to-lot variability.
The United States Pharmacopeia (USP) introduced new chapters in May 2025 permitting recombinant reagents (rCR, rFC) for endotoxin detection. Building on this regulatory milestone, SHENTEK offers a recombinant cascade reagent (rCR), providing an advanced and eco-sustainable alternative to conventional LAL tests, ensuring higher consistency, quality control, and safety assurance for pharmaceuticals.
The EndoSynXTM Recombinant Cascade Reagent (rCR) is a recombinant endotoxin detection system that mimics the enzymatic cascade of natural Limulus Polyphemus Lysate and it contains Recombinant Factor C, Recombinant Factor B, and Recombinant Proclotting Enzyme. Upon exposure to Gram-negative bacterial endotoxin (lipopolysaccharide, LPS), recombinant Factor C is activated, which will then activate the cascade enzyme system of serine, generating a kinetic chromogenic signal that correlates with the concentration of endotoxin. The EndoSynXTM rCR does not contain Factor G, eliminating interference from β-D-glucan and Limulus Amebocyte Lysate-reactive materials in test samples. The kit is suitable for quantitative determination of endotoxin in pharmaceutical products.
The kit is for RESEARCH USE ONLY and not intended for clinical use.
Application
1. Injectable drugs for human and veterinary use (e.g., chemical drugs, radiopharmaceuticals, antibiotics, biological products)
2. Medical devices - raw and auxiliary materials, intermediates, and finished products (e.g., dialysates, implantable devices)
Key Features - EndoSynXTM Recombinant Cascade Reagent (rCR) (Kinetic-Chromogenic Assay)
Equivalence in Endotoxin Detection: Recombinant Cascade Reagent vs. LAL Reagent
Superior Anti-Interference Capability
