- Testing Types
- Bacterial Endotoxin Testing
Terms and Conditions
Sample Submission Form
Overview
Endotoxins are toxic lipopolysaccharides (LPS) found in the outer cell wall of Gram-negative bacteria. When introduced into the body through contaminated pharmaceutical products or medical devices, they can trigger serious immune responses ranging from fever and inflammation to septic shock. At PLS Analytical, endotoxin assessments help manufacturers detect and control these contaminants before products reach patients.
PLS Analytical performs endotoxin testing to detect and quantify bacterial endotoxins in pharmaceutical products, biologics, medical devices, water systems, and raw materials. Using compendial methods, our testing supports injectable products, implantable and ophthalmic devices, lot release programs, water system monitoring, and other applications where endotoxin control is a critical quality requirement.
Unlike many microbial contaminants, endotoxins are highly persistent and cannot be reliably detected through routine sterility testing or easily removed once introduced into a product. Effective monitoring is therefore essential for maintaining product quality, protecting patient safety, and minimizing contamination risks throughout manufacturing.
PLS Analytical delivers scientifically rigorous endotoxin testing aligned with USP <85>, USP <161>), FDA guidance, and global regulatory expectations, helping manufacturers generate reliable data for product release, regulatory submissions, and ongoing quality assurance.
Testing Services
PLS Analytical utilizes the Limulus Amebocyte Lysate (LAL) assay, a widely accepted method for bacterial endotoxin detection across pharmaceutical products, biologics, and medical devices.
Chromogenic Method
Chromogenic Method
The Chromogenic Method quantitatively detects bacterial endotoxins through a colorimetric reaction using the Limulus Amebocyte Lysate (LAL) assay. Scientifically robust data supports high-precision testing, complex sample analysis, detailed endotoxin characterization, and regulatory submissions. The team has various equipment to conduct the studies, one such equipment mainly used will be Eclipse Analyzer.
Advantages
Product Integrity
Detects harmful bacterial endotoxins at trace levels to help ensure the safety of pharmaceutical products and medical devices, particularly injectables, biologics, and implantable devices.
Reliable Results
Validated LAL-based methods generate sensitive, reproducible data supported by controlled testing, method validation, and complete documentation for quality and regulatory confidence.
Early Detection & Source Control
Monitors raw materials, water systems, in-process samples, and finished products to identify contamination early and support effective root-cause investigations.
