Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

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
View All Articles in Issue

Page(s):  407-414

Quality Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 1 Page 1
Quality Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 1 Page 2
Quality Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 1 Page 3
Quality Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 1 Page 4
Quality Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 1 Page 5
Quality Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 1 Page 6
Quality Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 1 Page 7
Quality Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 1 Page 8

Download in electronic PDF format for $75

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

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Quality Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 1
Dubczak John
, Latta Kenneth S, Hedman Hilary, Smith Donald R
Sep/Oct 2010
Pg. 407-414

Quality-Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 2
Cooper James F
, Chakrabarty Kaushik, McGuire Jason, Zolner William J, Jones Vann, Hedman Hilary
Nov/Dec 2010
Pg. 493-506

Quality-Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 3: A Simplified Endotoxin Test Method for Compounded Sterile Preparations
Cooper James F
Jan/Feb 2011
Pg. 49-54

Quality Control Analytical Methods: End-preparation Assessments and Tests for Compounded Sterile Preparations
McElhiney Linda F
Jul/Aug 2013
Pg. 307-311

Compounding in the Pharmacy Curriculum: Beyond the Basics
Hinkle Amanda R
, Newton Gail D
May/Jun 2004
Pg. 181-185

The Role of Compounding in Closing Therapeutic Gaps--Abstracts from FIP 2013
Lutz Eugene
, Pauletti Giovanni, Carvalho Maria, Davidson Gigi, Ashworth Lisa, Subramaniam Vaiyapuri, Llambí Francesc
Jan/Feb 2014
Pg. 6-12

Microbiologic Testing for 503A Sterile-Compounding Pharmacies
Mixon William
, Roth Abby
May/Jun 2017
Pg. 193-203

Quality Control Analytical Methods: Pharmacopeial Bacterial Endotoxins Test Chapters
Dawson Michael E
Jul/Aug 2010
Pg. 317-320

Physicochemical and Microbiological Stability of Vancomycin 10-mg/mL Intravitreal Syringes
Bartoll Aaron Puplà
, Bellés Medall Maria Dolores, Peñarrocha Josep Edo, Escrig Laura Solaz, Clemente Ruben Eguren, Azuara Julia Bodega, Piqueres Raul Ferrando
Jul/Aug 2022
Pg. 330-335

Current Topical Treatments in Wound Healing - Part 1
Helmke Christopher D
Jul/Aug 2004
Pg. 269-274

Basics of Sterile Compounding: Intravenous Admixture Preparation, Part 12: United States Pharmacopeia Chapters Referenced in the Current United States Pharmacopeia Chapter <797> Pharmaceutical Compounding -- Sterile Preparations
Allen Loyd V Jr
Nov/Dec 2021
Pg. 491-496

Quality Control Analytical Methods: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 1
Vu Nicole
, Lou Jessica R, Kupiec Thomas
May/Jun 2014
Pg. 213-221

Summary of Quality-Control Testing for Sterile and Nonsterile Compounded Preparations, Part 2: Microbiological Testing
Allen Loyd V Jr
Jul/Aug 2019
Pg. 299-303

Single Center Experience with Robot Technologies for Sterile Compounding: A Retrospective Review
Milibari Loay
, Cotugno Michael, Belisle Caryn, Rocchio Megan, Patterson Robert F, Chacon Pablo, Fanikos John, Vo Peter
Jul/Aug 2020
Pg. 346-351

Quality-Control Analytical Methods: Microbial Testing Aspects of USP <797> for Compounded Sterile Preparations
Kupiec Thomas C
Jan/Feb 2005
Pg. 47-49

Quality-Control Analytical Methods: Overview of Beyond-Use Dating for Compounded Sterile Preparations
Trissel Lawrence A
Nov/Dec 2008
Pg. 524-528

Using Hospital Laboratory Services to Perform Quality-control Testing on Compounded Preparations
Donnelly Ronald F
Sep/Oct 2015
Pg. 383-386

Quality-Control Analytical Methods: Selecting an Analytical Method
Allen Loyd V Jr
Jan/Feb 2004
Pg. 61-64

Basics of Compounding: Application of the United States Pharmacopeia Bacterial Endotoxins Test to Compounded Sterile Preparations
Dawson Michael F
Jan/Feb 2006
Pg. 36-39

Quality-Control Analytical Methods: Designing a Quality-Control Potency Testing Program for a Compounding Pharmacy
Zolner William J
Sep/Oct 2009
Pg. 412-418

Return to Top