Low Endotoxin Recovery: Beyond the Controversy

This phenomenon is the masking of endotoxin in undiluted materials, and is thought to be attributable to combinations of specific excipients. This differs from the inhibition or interference of endo toxin tests caused by pH, high divalent ion concentrations, chelators, serine proteases and beta­glucans, which can usually be overcome using a pre­treatment such as dilution. This guide provides an overview of the challenges the pharmaceutical in­ dustry faces as a result of LER, an examination of the different responses to the LER challenge, and a review of the current status from a regulatory point of view.