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Air-sampled Filter Analysis for Endotoxins and DNA Content
Published on: March 7, 2016
Quality-control analytical methods: pharmacopeial bacterial endotoxins test chapters
1Associates of Cape Cod, Inc., E. Falmouth, Massachusetts.
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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Effects of EDTA on End-Point Detection Methods
In the visual method, metal-ion indicators (metallochromic dyes), which have distinct colors in their free and complex forms, are added to the mixture to signal the titration's end point. They form stable complexes with metal ions, but these complexes are weaker than the corresponding metal–EDTA complexes. As a result, EDTA...

