RT Journal Article
SR Electronic
T1 Depyrogenation of a Parenteral Solution by Ultrafiltration
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 3
OP 7
VO 35
IS 1
A1 Abramson, D.
A1 Butler, L. D.
A1 Chrai, S.
YR 1981
UL http://journal.pda.org/content/35/1/3.abstract
AB 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.