What are endotoxins?
Endotoxins are a toxic substance found in the cell wall of gram negative bacteria and released when the bacteria ruptures.  The release of endotoxin in the body can cause a range of symptoms, such as fever, hypertension, shock, and disseminated intravascular coagulation.

The Limulus Amebocyte Lysate (LAL) test is an invitro assay for detection and quantitation of bacterial endotoxins.

Routine Analysis
Endotoxin analysis should be accurate and objective.  Why be unsure if the gel formed, when you can know for sure what is there?  With each test run we perform a system suitability on your product which tells us if there is interference or true endotoxin present.  No matter the product; oils, suspensions, radiopharmaceuticals - we have a method that can work for you.  We can help you calculate the endotoxin limit on all your drugs or do it for you.  Let us help you confidently deliver a safe and reliable product to the ones you serve.

Method Development and Validation

We offer a variety of services for your endotoxin needs.  Whether its method development for a new product line or routine endotoxin testing, we can help.   

• Validated test methods require that we test three different lots to pass the following criteria:
• Absolute value of the R-value > 0.98
• Negative Water Controls (NWC) > lambda onset times
• CV’s between standards and Positive Product Controls < 10%
• CV’s between unknowns < 20%
• Spike Recovery for each lot of product must be between 50% and 200%
• pH of Sample + LAL between 6 and 8

Endotoxin testing is necessary for:

• Injectables or parenteral products
• Radiopharmaceuticals and cytotoxic agents
• Water for injection (WFI)
• Validation of depyrogenation processes

Source of endotoxin contamination:

• Water
• Raw compounds
• Instruments
• Method of storage between preparation and sterilization
• Inadequate depyrogenation cycle

Inadequate depyrogenation cycles