Bacterial Endotoxin Test or BET is a valuable quality control method for the detection and quantitation of endotoxins, which are pathogenic components found in the outer membranes of gram-negative bacteria. The endotoxins can cause life-threatening illnesses like fever, inflammation, and septic shock when introduced into the body through injectable medications or medical devices.

At Chromak Research, we provide USP <85> compliant BET services via the Limulus Amoebocyte Lysate (LAL) gel-clot test. Our testing verifies that your pharmaceutical or medical device products are regulatory safe and free of cytotoxic endotoxin contamination.

What Is Bacterial Endotoxin Testing?

USP <85> Bacterial Endotoxins Test describes the accepted methods of endotoxin detection, typically the gel-clot method. This in-vitro test employs lysate from horseshoe crab blood (Limulus polyphemus). When endotoxins are present, the lysate responds to form a gel clot, which constitutes a positive reaction.

Endotoxin testing is required for:

Parenteral drug products

Medical devices that come into contact with blood or cerebrospinal fluid

Bulk drug substance and excipients

Water for Injection (WFI) and purified water

Biologics, vaccines, and ophthalmic products

Our Approach to Testing at Chromak Research

At Chromak Research, we conduct the gel-clot LAL test, a qualitative procedure with good sensitivity. The test is very common in the drug industry with respect to its reliability and acceptability by regulatory bodies.

Basic Features of Our Testing:

USP <85> Tests Preparatory

Prior to testing, we perform a check for lysate sensitivity and screen for possible inhibitory or potentiating factors contained within the sample matrix. These processes validate test suitability and provide correct results.

Validated Methods

All testing is performed in accordance with USP <85> procedures and cGMP requirements, with integrity of data and compliance for regulatory filings.

Detection Sensitivity

Our gel-clot procedure detects as low as possible levels of endotoxin, based on the lysate employed and tested product.

Materials We Test

Our lab conducts BET on a variety of materials, such as:

  • Injectable suspensions and solutions

  • Raw materials and APIs

  • Biopharmaceuticals and cell culture media

  • Medical devices like implants, catheters, and syringes

  • Sterile water systems (purified water, WFI)

Importance of Endotoxin Testing

In contrast to microbial contaminants, endotoxins are heat-resistant and cannot be eliminated by routine sterilization. Endotoxin presence in pharmaceutical or medical products may jeopardize the safety of patients and lead to regulatory non-compliance, recalls, or product delays.

Bacterial endotoxin testing is not only a routine requirement for compliance with regulations by agencies such as the FDA, EMA, and USP, but also an essential component of good manufacturing and quality assurance practices.

Why Chromak Research?

Chromak Research provides accurate, efficient, and regulation-compliant endotoxin testing services to meet your product requirements. With pharma microbiology expertise, we ensure on-time turnaround, qualified advice, and correct reporting.

What Separates Us:

USP <85> and cGMP compliance

Staff of trained microbiology test technicians

Validated LAL gel-clot procedures

Large-scale testing of raw materials, in-process, and finished products

We are committed to delivering you with accurate, reproducible, and defensible-by-regulators information to serve your product introduction and quality assurance plans.