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VOL. 30, NO. 2 Download (512K PDF)
Low Endotoxin Recovery (LER): A Review
Letter From The Editor
The LAL Update addresses the issue of low endotoxin recovery (LER). This has been a topic of considerable discussion and interest since it was first identified by Chen and Vinthers in the spring of 2013 at the Annual Meeting of the Parenteral Drug Association in Orlando, FL. The issue concerns the inability to detect some or all of the endotoxin added to certain drug products or components of drug product. The issue has caught the attention of FDA because it raises the concern that contaminant endotoxin in drug products might not be detect during release testing. The concern is heightened by reports that samples to which endotoxin has been added but in which it is not detectable in by the bacterial endotoxins test using LAL reagent, were pyrogenic in pyrogen tests performed with rabbits.
The recognition of the LER issue increases the importance of proper method development and validation so that endotoxin in product (whether present as a contaminant or because it has been added) is appropriately detected. The Contract Test Service at Associates of Cape Cod, Inc., has extensive experience in overcoming a wide range of interference problems or masking of endotoxin, including LER, in a wide range of sample matrices. If you are having difficulty with LER, please contact Dr. Barbara Markley at firstname.lastname@example.org
, 888-232-5889 or 508-540-3444.
With best wishes,
Michael E. Dawson, Ph.D., RAC
Director of Regulatory Affairs