Endotoxins are toxins released by bacteria, primarily composed of lipopolysaccharides, and are widely present in Gram-negative bacteria. Once endotoxins enter the human body, they can trigger a strong immune response, potentially causing fever, low blood pressure, shock, and even death. Therefore, endotoxin testing is crucial to ensure the safety of pharmaceuticals, medical devices, and biologics, particularly in clinical and production environments.
MtoZ Biolabs offers endotoxin testing using the gel clot method, kinetic chromogenic method, and recombinant cascade reagent (rCR) kinetic-chromogenic assay. The gel clot method is suitable for qualitative testing, while the kinetic chromogenic method enables quantitative analysis. The rCR reagent avoids interference from β-glucans through its recombinant enzyme system, providing higher specificity and sensitivity. These methods are widely used in endotoxin testing for pharmaceuticals, medical devices, cell cultures, and biologics, ensuring the quality and safety of products.
Advantages
✅ Broad Dynamic Range
The Limulus Amebocyte Lysate (LAL) Reagent (Gel Clot Method) quickly and easily detects the presence of endotoxins from Gram-negative bacteria in test samples, with a sensitivity range of 0.03 to 0.5 EU/mL, effectively capturing trace amounts of endotoxins to meet various safety evaluation needs.
✅ High Specificity
Our recombinant cascade reagent (rCR) system eliminates the interference of G factor found in traditional LAL reagents and removes false positives caused by glucans, ensuring target-specific detection.
✅ Multi-Matrix Compatibility
Extensively validated, this series of products is compatible with a wide range of sample types, including serum, plasma, recombinant proteins, vaccines, cell culture supernatants, and various medical device eluates, effectively handling complex biological sample testing.
✅ Compliance with Regulations
Complies with the requirements of the United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP).
Technical Support
1. Protocol Downloads
MtoZ Biolabs provides comprehensive experimental protocols and product manuals to help ensure smooth and reproducible workflows. For access to specific documents or detailed instructions, please contact our support team.
2. Customized Service Support
Our experienced scientists offer tailored technical assistance and customized solutions based on your specific research goals, helping you achieve optimal experimental outcomes.
3. FAQ and Expert Assistance
We provide responsive and professional technical support to address your questions efficiently. Our experts are ready to help you identify and resolve experimental challenges quickly and accurately.
