Abstract

Quality Control Analytical Methods: Pharmacopeial Bacterial Endotoxins Test Chapters

Author(s): Dawson Michael E

Issue: Jul/Aug 2010 - Sterile Compounding

Page(s): 317-320

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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.

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