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Quality-Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 2

Author(s):  Cooper James F, Chakrabarty Kaushik, McGuire Jason, Zolner William J, Jones Vann, Hedman Hilary

Issue:  Nov/Dec 2010 - Volume 14, Number 6
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Abstract:  Ensuring that the endotoxin burden in sterile preparations is within allowable limits is one of the greatest challenges faced by compounding pharmacists. Today, endotoxin analyses can be performed in the pharmacy with a test kit or accomplished by sending samples to a contract testing laboratory. Both types of screening are discussed in this article, and information that enables compounders to determine the preferred method of endotoxin testing is provided. A brief history of endotoxin testing is presented, and the advantages and disadvantages of pyrogen screening with either an in-house test kit or the services of a contract testing laboratory are explored. Accurate screening for pyrogens ensures that only sterile formulations containing a safe level of endotoxins are dispensed. An essential task in sterile compounding, endotoxin testing safeguards patients against the morbidity and mortality that can result from treatment with a contaminated preparation.

Related Keywords: James F. Cooper, PharmD, FAPhA, Kaushik Chakrabarty, MS, Jason McGuire, William J. Zolner, PhD, Vann Jones, Hilary Hedman, BS, MBA, endotoxin testing, compounded sterile products, pyrogen screening, standard operating procedure, flowchart, in-house test kits, endotoxin limits

Related Categories: HISTORY, SOPs, STERILE PREPARATIONS, QUALITY CONTROL

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