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.

Quality Control Analytical Methods: Pharmacopeial Bacterial Endotoxins Test Chapters

Author(s):  Dawson Michael E

Issue:  Jul/Aug 2010 - Sterile Compounding
View All Articles in Issue

Page(s):  317-320

Quality Control Analytical Methods: Pharmacopeial Bacterial Endotoxins Test Chapters Page 1
Quality Control Analytical Methods: Pharmacopeial Bacterial Endotoxins Test Chapters Page 2
Quality Control Analytical Methods: Pharmacopeial Bacterial Endotoxins Test Chapters Page 3
Quality Control Analytical Methods: Pharmacopeial Bacterial Endotoxins Test Chapters Page 4

Download in electronic PDF format for $65

Abstract:  This article summarizes and explains the essential provisions of the harmonized Bacterial Endotoxins Test chapter. The bacterial endotoxins test is an important requirement of United States Pharmacopeia Chapter <797>, Pharmaceutical Compounding—Sterile Preparations, which requires endotoxin testing of high-risk compounded sterile preparations. This article includes recommendations on endotoxin testing.

Related Keywords: Michael E. Dawson, PhD, RAC, United States Pharmacopeia, USP Chapter <85> Bacterial Endotoxins Test, BET chapter, compounded sterile preparations, bacterial endotoxins testing, Chapter <797> Pharmaceutical Compounding -- Sterile Preparations, limulus amoebocyte lysate, LAL test, gel-clot technique, turbidimetric technique, chromogenic technique, photometric techniques

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

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

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

PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>,<797>, and <825>: Part 1
Allen Loyd V Jr
Mar/Apr 2020
Pg. 92

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

PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>, <797>, and <825>: Part 2
Allen Loyd V Jr
May/Jun 2020
Pg. 180

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

Update on the Proposed Revision Process for United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations
Okeke Claudia C
Jul/Aug 2007
Pg. 302-305

Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 3: Risk Levels
Allen Loyd V Jr
, Okeke Claudia C
Sep/Oct 2007
Pg. 404-410

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

Particle Measuring Systems - USP <797> Environmental Monitoring Solutions