Abstract
The dry heat destruction of Escherichia coli endotoxin in Type I glass vials was studied at three oven operating temperatures, namely, 175 °C, 210 °C, and 250 °C, utilizing typical processing conditions in both a connective and a radiant heating oven. Also, five different lots of E. coli endotoxin were compared, three of which were a standard commercial endotoxin and two were a purified lipopolysaccharide. A total of 5265 samples of endotoxin were tested using the Limulus Amebocyte Lysate gel endpoint test, having a sensitivity of 0.005 ng/0.1 ml. It was found that destruction of endotoxin occurred in a time equivalent to F54170 values at 130,150, and 1800 min, respectively, for the three temperatures utilized.
- Received November 19, 1986.
- Accepted January 20, 1987.
- Copyright © Parenteral Drug Association. All rights reserved.
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