Abstract
This paper will discuss theory, techniques, and applications of ultrafiltration using a 10,000 molecular weight cutoff ultrafiltration system. It has been determined by LAL tests that four log and two log reductions in the E. coli endotoxin content of water and a parenteral solution, respectively, can be achieved in a single-pass system. The amount of endotoxin removed depends upon the design of the system and the load of endotoxin in the parenteral solution. The significance of these findings is discussed, and correlation with the USP rabbit test is made. Modifications made to improve the performance of the system are also discussed.
- Received September 6, 1980.
- Accepted December 11, 1980.
- Copyright © Parenteral Drug Association. All rights reserved.
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