Endotoxin analysis

The Endotoxin Analysis is a laboratory test designed to detect and quantify bacterial endotoxins in suitable samples using the LAL (Limulus Amebocyte Lysate) assay.

The analysis is intended for liquid solutions and lyophilised samples in vials. Results are reported in endotoxin units (EU), either per vial or per millilitre depending on the sample format.

About Endotoxins

Endotoxins are lipopolysaccharides (LPS) found in the outer membrane of Gram-negative bacteria. They can remain present even after bacterial cells are no longer viable and are therefore an important quality and safety parameter for pharmaceutical and laboratory products.

The LAL assay is widely used for the detection and quantification of bacterial endotoxins due to its high sensitivity.

Key Features

• Detection and quantification of bacterial endotoxins
• Analysis by LAL assay
• Suitable for liquid solutions and lyophilised samples in vials
• Results for lyophilised samples reported in EU/vial
• Results for liquid solutions reported in EU/ml
• Minimum sample amount of 1 ml solution or 1 vial
• Standard analysis accurately quantifies values up to 10 EU/vial
• Average turnaround time of 7 business days

Analysis Parameters

• Testing method: LAL assay
• Amount of sample required: 1 ml solution or 1 vial
• Result format for vial with lyophilisate: EU/vial
• Result format for liquid solution: EU/ml
• Average turnaround time: 7 business days

Important Notice

• The standard endotoxin analysis provides accurate results for values up to 10 EU/vial. Values above 10 EU/vial are estimated.
• If a fully quantitative result above this range is required, an additional test using another vial and an appropriate dilution is necessary. Sending two vials is therefore recommended when elevated endotoxin levels may be expected.
• If values above 10 EU/vial are expected in advance, this should be communicated before testing so that the sample can be analysed using an appropriately calibrated procedure.
• Endotoxin analysis is not offered for oils, raw API powders, tablets, or capsules.

Optional Additional Analyses

The following optional laboratory services are available:

• Additional Laboratory Report