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Quality Control Analytical Methods: Pharmacopeial Bacterial Endotoxins Test Chapters

Author(s):  Dawson Michael E

Issue:  Jul/Aug 2010 - Sterile Compounding
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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.

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

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