RT Journal Article
SR Electronic
T1 Destruction of Challenged Endotoxin in a Dry Heat Oven
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 59
OP 63
VO 48
IS 2
A1 Nakata, Tohru
YR 1994
UL http://journal.pda.org/content/48/2/59.abstract
AB ABSTRACT: The amount and pyrogenicity of challenged endotoxin (derived from E. coli 055:B5, 10,000 endotoxin units, EU) processed in a dry heat oven at 200° and 250°C was measured and compared with the predicted amount and pyrogenicity calculated from destruction kinetics. The values for the assayed amount and pyrogenicity of the endotoxin processed in the dry heat oven at 200° and 250°C were fairly close to the predicted values. When the challenged endotoxin was exposed for 60 min in a dry heat oven at 200°C, the amount of destruction did not reach a 3 log cycle reduction, although the pyrogenicity of the endotoxin was sufficiently reduced. However, at 250°C for 30 min in the dry heat oven, the amount of endotoxin destroyed quickly reached a 3 log cycle reduction, and the pyrogenicity was quickly reduced to a sufficient level.