Endotoxin test
Endotoxins are naturally occurring components of certain bacterial cells.
When these cells die and break apart, endotoxins are released into the surrounding environment, making their detection and control critical for product safety and quality.
These components are toxic if administered to humans and/or animals, causing a pyrogenic response (rise in body temperature). For this reason, it is important that drugs and medical devices which are either injected or implanted are tested for their endotoxin content.
Endotoxin detection tests verify the safety, namely absence of endotoxins, in sterile pharmaceutical products intended for human consumption.
Principle of test
Kinetic chromogenic method and kinetic turbidimetric method
Eurofins BioPharma Product Testing New Zealand can perform both the kinetic chromogenic and turbidimetric assays, both of which are quantitative in nature and use measurements to determine endotoxin content. These tests have a turnaround time of 3-5 days from sample receipt.
Gel clot assay method
The gel clot assay is a qualitative Limulus amebocyte lysate (LAL) test which relies upon the operator to visually assess the formation (or lack thereof) of a gel clot in the reaction tubes.
Sample requirements and turnaround times
Generally, one container is sufficient for method qualification purposes. For validation of a new product, the pharmacopoeias require samples from three separate batches to be tested to ensure any batch-to-batch variation is taken into account.
Routine test results can be completed in 3 – 5 days. Validations can be completed in approximately 21 – 28 days.
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