Application Note

Broad spectrum pyrogen detection

Format: PDF file | Document type: Application Note | Promoted Content

This Application Note has been written by EMD Millipore , and any views and opinions expressed do not necessarily reflect those of www.outsourcing-pharma.com

Broad spectrum pyrogen detection according to pharmacopoeia

The Monocyte-Activation Test (MAT), which was introduced into the European Pharmacopoeia in 2010, detects pyrogens in pharmaceuticals. It covers a much broader range of pyrogens than the LAL Test, which traces only endotoxins. As an alternative to rabbit pyrogen testing (1) (2), the MAT allows better standardization and does not require animal consumption.

This paper shows the results of detection tests for a broad range of pyrogens using a commercially available MAT, EMD Millipore’s PyroDetect System. It explains the principle behind the MAT and illustrates how to perform a test in your lab.

References:

(1): EP 6.7 chapter 2.6.30

(2): FDA Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers June 2012

Supplier info centre