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Quality Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 1

Author(s):  Dubczak John, Latta Kenneth S, Hedman Hilary, Smith Donald R

Issue:  Sep/Oct 2010 - Supporting Quality Pharmaceutical Compounding World Wide
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Abstract:  Inadvertent exposure to endotoxins administered intravenously, intramuscularly, or intrathecally can cause a constellation of adverse effects that range from fever to multiple organ failure and death. Pharmacists who compound sterile formulations must remain exceptionally vigilant to guard against the contamination of such preparations with those pyrogens. Fortunately, endotoxin screening analyses are available for onsite use or from contract testing laboratories, and both options offer accurate, repeatable, and timely results. The volume of sterile compounding performed, the need for immediate results, and cost often dictate the compounder’s choice of endotoxin testing. In this first of a 3-part series, we summarize the evolution of pyrogen screening and explain the mechanisms of two endotoxin test kits that provide valid results on site. A table comparing those kits is presented for easy reference. In part 2 of the series, additional endotoxin test kits will be compared, and contract laboratory pyrogen testing will be profiled. In part 3, a simplified endotoxin test method for compounded sterile products will be presented.

Related Keywords: John Dubczak, BS, Kenneth S. Latta, BS, RPh, Hilary Hedman, BS, MBA, Donald R. Smith, compounded sterile preparations, aseptic compounding, pyrogens, endotoxin testing, contamination, limulus amebocyte lysate, LAL testing, quality assurance

Related Categories: STERILE PREPARATIONS, QUALITY CONTROL

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