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 3: A Simplified Endotoxin Test Method for Compounded Sterile Preparations

Author(s):  Cooper James F

Issue:  Jan/Feb 2011 - Volume 15, Number 1
View All Articles in Issue

Page(s):  49-54

Quality-Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 3: A Simplified Endotoxin Test Method for Compounded Sterile Preparations Page 1
Quality-Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 3: A Simplified Endotoxin Test Method for Compounded Sterile Preparations Page 2
Quality-Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 3: A Simplified Endotoxin Test Method for Compounded Sterile Preparations Page 3
Quality-Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 3: A Simplified Endotoxin Test Method for Compounded Sterile Preparations Page 4
Quality-Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 3: A Simplified Endotoxin Test Method for Compounded Sterile Preparations Page 5
Quality-Control Analytical Methods: Endotoxins: Essential Testing for Pyrogens in the Compounding Laboratory, Part 3: A Simplified Endotoxin Test Method for Compounded Sterile Preparations Page 6

Download in electronic PDF format for $75

Abstract:  The first two parts of the IJPC series on endotoxin testing explained the nature of pyrogenic contamination and described various Limulus amebocyte lysate methods for detecting and measuring endotoxin levels with the bacterial endotoxin test described in the United States Pharmacopeia. This third article in that series describes the endotoxin test that is simplest to perform for pharmacists who prefer to conduct an endotoxin assay at the time of compounding in the pharmacy setting.

Related Keywords: James F. Cooper, PharmD, FAPHA, sterile compounding, endotoxin testing, pyrogens, quality assurance, United States Pharmacopeia Chapter <797>, Limulus amebocyte lysate, bacterial endotoxin test, standards, intrathecal administration, intraspinal infusion, intravenous administration, intramuscular administration, patient-controlled analgesia, endotoxin limits, erectile dysfunction injectables, carboxymethylcellulose, injectable suspensions, standard operating procedure

Related Categories: PARENTERALS, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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 3: A Simplified Endotoxin Test Method for Compounded Sterile Preparations
Cooper James F
Jan/Feb 2011
Pg. 49-54

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 1
Dubczak John
, Latta Kenneth S, Hedman Hilary, Smith Donald R
Sep/Oct 2010
Pg. 407-414

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

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

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

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

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

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

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

Sterile Basics of Compounding: Allowable Endotoxin Levels in Parenteral Preparations
Allen Loyd V Jr
Nov/Dec 2023
Pg. 483-486

Quality-Control Analytical Methods: Chemical Testing Aspects of USP <797> for Compounded Sterile Preparations
Kupiec Thomas C
Mar/Apr 2005
Pg. 136-138

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

Incorporating Quality Assurance in Pharmaceutical Compounding-related Courses in the PharmD Curricula
Hossain Mohammad Faisal
, Levesque Dan, Frye John, Rashid Mamoon
Jul/Aug 2020
Pg. 322-326

Quality Control: Rapid Sterility Testing for Compounding Pharmacies
Taylor Andrew
Jul/Aug 2020
Pg. 299-303

Comparison of Endotoxin Testing Methods for Pharmaceutical Products
Joiner Timothy J
, Kraus Paul F, Kupiec Thomas C
Nov/Dec 2002
Pg. 408-409

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

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

Quality Control: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 2
Vu Nicole
, Lou Jessica R, Kupiec Thomas C
Jul/Aug 2014
Pg. 305-310

Quality-Control Analytical Methods: High-Performance Liquid Chromatography
Kupiec Thomas C
May/Jun 2004
Pg. 223-227

Return to Top