Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Basics of Compounding: Application of the United States Pharmacopeia Bacterial Endotoxins Test to Compounded Sterile Preparations

Author(s):  Dawson Michael F

Issue:  Jan/Feb 2006 - Sports Medicine
View All Articles in Issue

Page(s):  36-39

Basics of Compounding: Application of the United States Pharmacopeia Bacterial Endotoxins Test to Compounded Sterile Preparations Page 1
Basics of Compounding: Application of the United States Pharmacopeia Bacterial Endotoxins Test to Compounded Sterile Preparations Page 2
Basics of Compounding: Application of the United States Pharmacopeia Bacterial Endotoxins Test to Compounded Sterile Preparations Page 3
Basics of Compounding: Application of the United States Pharmacopeia Bacterial Endotoxins Test to Compounded Sterile Preparations Page 4

Download in electronic PDF format for $65

Abstract:  This article introduces endotoxins and the application of the bacterial endotoxins (pyrogen) test to test for endotoxins in a manner compliant with the United States Pharmacopeia–National Formulary Chapter <797> Pharmaceutical Compounding—Sterile Preparations, the intent of which is to prevent harm and fatality to patients which could result from microbial contamination (nonsterility), excessive bacterial endotoxins, or compounding errors. Basic information about endotoxins is supplied in this article, along with information on testing methods. The purpose of this article is to assist compounding pharmacists to develop a documented system in which the quality of the components and the compounding procedure are well controlled and testing for endotoxins becomes a formality.

Related Keywords: Michael F. Dawson, PhD, United States Pharmacopeia, USP, bacterial endotoxins test, pyrogens, sterile preparations, bacteria, LAL test, quality assurance testing, contamination, contaminants

Related Categories: 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
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: End-preparation Assessments and Tests for Compounded Sterile Preparations
McElhiney Linda F
Jul/Aug 2013
Pg. 307-311

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

Quality Control: Minor Chapters, Major Impacts: What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> Mean for Your Compounding Practice
Kelley Brian
Mar/Apr 2021
Pg. 115-124

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 Assurance and Quality Control, Part 2
Akers Michael J
May/Jun 2015
Pg. 215-221

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

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 Assurance and Quality Control, Part 1
Akers Michael J
Mar/Apr 2015
Pg. 121-124