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Chromogenic Endotoxin Quantification Kit for Accurate Bacterial Toxin Measurement
Endotoxins, also known as lipopolysaccharides (LPS), are toxic components of the outer membrane of Gram-negative bacteria. Their presence in pharmaceuticals, medical devices, and other sterile products can lead to severe inflammatory responses in humans. Accurate detection and quantification of endotoxins are critical to ensuring product safety and compliance with regulatory standards.
Why Choose a Chromogenic Endotoxin Quant Kit?
The Chromogenic Endotoxin Quant Kit provides a highly sensitive and reliable method for measuring endotoxin levels. Unlike traditional Limulus Amebocyte Lysate (LAL) tests, this kit utilizes a chromogenic substrate that produces a measurable color change in the presence of endotoxins. This allows for precise quantification using a spectrophotometer, reducing subjectivity and improving accuracy.
Key Features of the Kit
- High Sensitivity: Detects endotoxin levels as low as 0.005 EU/mL.
- Wide Dynamic Range: Suitable for both low and high endotoxin concentrations.
- Fast Results: Provides quantifiable data in under 60 minutes.
- Standardized Assay: Complies with USP, EP, and JP pharmacopeial guidelines.
Applications of the Chromogenic Endotoxin Quant Kit
This kit is widely used in pharmaceutical quality control, biotechnology research, and medical device testing. It is particularly valuable for:
- Batch testing of injectable drugs and vaccines.
- Monitoring endotoxin levels in cell culture media.
- Validating cleaning procedures in manufacturing facilities.
How the Kit Works
Keyword: Chromogenic Endotoxin Quant Kit
The chromogenic assay is based on the activation of a proenzyme by endotoxins, which then cleaves a synthetic chromogenic substrate. The resulting color intensity is directly proportional to the endotoxin concentration and can be measured at 405 nm. The kit includes pre-diluted standards, controls, and a detailed protocol to ensure reproducibility.
Advantages Over Traditional Methods
Compared to gel-clot or turbidimetric LAL tests, the chromogenic method offers:
- Quantitative Precision: Eliminates the need for subjective interpretation.
- Reduced Variability: Minimizes operator-dependent errors.
- Automation Compatibility: Easily integrated into high-throughput workflows.
Conclusion
The Chromogenic Endotoxin Quant Kit is an essential tool for laboratories requiring accurate and reproducible endotoxin measurements. Its sensitivity, speed, and compliance with regulatory standards make it a preferred choice for quality assurance in the pharmaceutical and biotechnology industries.