Bacterial Endotoxin Testing - LAL Test

If you need Limulus Amebocyte Lysate (LAL) bacterial endotoxin testing performed, Boston Analytical offers rapid turnaround and the highest quality control standards in the industry. Currently working with pharmaceutical and medical device industries worldwide, Boston Analytical excels at meeting client needs, while providing accurate, quality results.

Bacterial Endotoxin Testing at Boston Analytical

What is Bacterial Endotoxin Testing?

Endotoxin testing utilizes LAL for minute levels of endotoxin that would affect sensitive trials and confirm the absence (or presence) of dangerous bacterial endotoxins.

Boston Analytical performs three forms of Endotoxin testing of which the LAL test battery include:

  • Gel Clot Bacterial Endotoxin Testing
  • Kinetic Chromogenic Bacterial Endotoxin Testing
  • Kinetic Turbidimetric Bacterial Endotoxin Testing

Endotoxin, once present in the manufacturing process stream, is not easily removed through traditional sterilization methods. When introduced into the bloodstream, bacterial endotoxins are known to elicit adverse effects. It is critical to determine the presence of bacterial endotoxin during all processes of product manufacturing.

During the production phase, Boston Analytical tests for the presence of bacterial endotoxins and delivers testing results during each phase, including:

  • Raw Material Testing
  • Water Quality Testing
  • In-Process Intermediate Testing
  • Bulk Lot Release Testing
  • Final Product Release Testing

Gel Clot Bacterial Endotoxin Testing

The gel clot bacterial endotoxin test visually indicates the presence of bacterial endotoxin through the formation of a clot following a 60 minute incubation period. Per USP <85>, the gel clot technique is used as the referee method in the event that the results of kinetic chromogenic or kinetic turbidimetric methods are inconclusive (e.g. interference).

Used as a limit assay test, Boston Analytical follows strict guidelines for levels of allowed endotoxins as observed by mixing reagents with diluted or undiluted samples and identifying clot formations.

Kinetic Chromogenic Bacterial Endotoxin Testing

Part of the USP <85> method of bacterial endotoxin testing, the kinetic chromogenic test quantitatively determines the endotoxin levels present based on the color change that results during incubation. The kinetic chromogenic method is the ideal test when considering speed, sensitivity and absolute quantitation.

Utilizing spectrophotometry to observe the chromogenic peptide release of the substrate, a chromophore, the accuracy and sensitivity of this test deliver the quality analysis you require.

Kinetic Turbidimetric Bacterial Endotoxin Testing

The kinetic turbidimetric test is a quantitative bacterial endotoxin method included in USP <85>, that measures levels of endotoxin though the measurement of the rate at which turbidity occurs in the presence of turbidimetric-specific lysate. This measurement is monitored through a spectrometer during the test incubation period.

The kinetic turbidimetric test is a particularly robust bacterial endotoxin method as it is not impacted by the color of the sample being analyzed as easily as the kinetic chromogenic method while still maintaining the same level of assay sensitivity.

Boston Analytical's microbiological testing facilities, with rapid turnaround times and quality results, have been utilized by pharmaceutical and medical device manufacturers from around the world with client retention being one of our main goals.

To learn how Boston Analytical can meet your Bacterial Endotoxin Testing needs, contact us today.