# Pyrogen Detection Kit for Accurate and Reliable Endotoxin Testing

## Introduction to Pyrogen Detection Kits

Pyrogen detection kits are essential tools in the pharmaceutical and medical device industries for ensuring product safety. These kits are specifically designed to detect and quantify endotoxins, which are pyrogenic substances derived from the outer membrane of Gram-negative bacteria. Accurate endotoxin testing is critical to prevent adverse reactions in patients receiving injectable drugs or medical implants.

## Why Choose Our Pyrogen Detection Kit?

Our pyrogen detection kit offers several advantages for your endotoxin testing needs:

– High sensitivity with low detection limits
– Excellent reproducibility across multiple tests
– Compatibility with various sample types
– Compliance with international pharmacopeia standards
– Time-saving compared to traditional rabbit pyrogen tests

## How the Pyrogen Detection Kit Works

The kit utilizes a chromogenic or turbidimetric method based on the Limulus Amebocyte Lysate (LAL) reaction. When endotoxins are present in the sample, they activate the LAL enzyme cascade, leading to either color development (chromogenic) or turbidity formation (turbidimetric) that can be measured spectrophotometrically.

### Key Components of the Kit

– LAL reagent
– Control standard endotoxin (CSE)
– Sample diluent
– Reaction buffer
– Color developer (for chromogenic method)

## Applications of Pyrogen Detection Kits

Our pyrogen detection kits are widely used in various applications:

– Quality control of parenteral pharmaceuticals
– Testing of medical devices and implants
– Monitoring of water for injection (WFI) systems
– Research and development of new drug formulations
– Environmental monitoring in cleanrooms

## Regulatory Compliance

Our pyrogen detection kits meet the requirements of major pharmacopeias including:

– United States Pharmacopeia (USP)
– European Pharmacopoeia (EP) 2.6.14
– Japanese Pharmacopoeia (JP) 4.01

## Technical Specifications

Parameter | Specification
Detection Range | 0.005 – 50 EU/mL
Sample Volume | 50 – 100 μL
Incubation Time | 10 – 30 minutes
Storage Conditions | 2-8°C
Shelf Life | 12 months

## Ordering Information

For ordering our pyrogen detection kits or requesting more technical information, please contact our customer service team. We offer various kit sizes to accommodate different testing volumes and requirements.

## Customer Support and Training

We provide comprehensive technical support and training to ensure proper implementation of our pyrogen detection kits in your quality control processes. Our experts are available to assist with method validation, troubleshooting, and regulatory compliance questions.