Bacterial Endotoxin Testing

Ensure your medical devices are free from harmful pyrogens with our Bacterial Endotoxin Testing (BET) services. Conducted as per USP <85>, EP, and ISO 10993-11 standards, our LAL-based testing detects endotoxins from gram-negative bacteria with high sensitivity. Ideal for injectables, implants, and surgical instruments, our certified labs deliver accurate results and regulatory compliance support. Partner with us to guarantee patient safety, meet global submission requirements, and maintain quality assurance for sterile medical devices.

Method Ref.: USP, IP, BP

TAT : 4 - 5 Working Days

Required sample quantity : 12 test units per product/batch*

Method Reference

USP, IP, BP

Turnaround Time

4 - 5 Working Days

Sample Quantity

12 test units per product/batch*

₹3,200 ₹4,000/ sample

NABL Accredited ISO 17025:2017 Signed Report

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Testing Scope

About This Test

The Bacterial Endotoxin Test (BET) is a critical quality control procedure used to detect and quantify endotoxins—pyogenic substances originating from gram-negative bacteria—in medical devices. These endotoxins, if present, can cause severe inflammatory reactions when introduced into the body. BET is especially important for devices that come in contact with blood, cerebrospinal fluid, or are used in implantable and injectable applications. Conducted using the Limulus Amebocyte Lysate (LAL) method as per USP <85>, BP, and IP, the test ensures that endotoxin levels are within safe limits. BET is essential for patient safety, regulatory approval, and product release.

Why It Matters