Endotoxin Detection Kits

Description

✔️ Technologies and Types of Endotoxin Detection Kits
Endotoxin assays are mainly based on internationally accepted analytical platforms, including:
🔹 LAL (Limulus Amebocyte Lysate)-based assays, such as:
⦁ Gel-Clot
Qualitative presence/absence testing with defined sensitivity limits
⦁ Chromogenic Assays
Quantitative measurement based on color development — high sensitivity
⦁ Turbidimetric Assays
Quantitative measurement based on turbidity change — suitable for automation
🔹 rFC (Recombinant Factor C) Assays
A non-animal-derived alternative with high specificity and sensitivity for endotoxins.
✔️ Sensitivity & Applications
Depending on the assay format and system, sensitivities commonly range from:
0.005 to 50 EU/mL (or lower)
Typical applications include:
✓ Injectable and sterile pharmaceuticals
✓ Biopharmaceutical and recombinant products
✓ Process and purified water (PW/WFI)
✓ Raw materials and intermediates
✓ QC and R&D laboratory testing
✔️ Leading Global Manufacturers
Well-recognized suppliers of endotoxin detection systems include:
Endosafe (Charles River), Lonza, and Cape Cod
Their products are designed to comply with USP, EP, and JP regulatory standards and are widely used in pharmaceutical QC laboratories worldwide.

🌿 OrchidGen — Your Trusted Supply Partner
OrchidGen supports pharmaceutical and biotechnology companies in Iran by
supplying a wide range of Endotoxin Detection Kits tailored to the specific technical and regulatory needs of each customer.
Our services include:
✔ Technical consultation and product selection
✔ Reliable and compliant product sourcing
✔ Scientific and documentation support