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J Pharm Sci Technol. 1994 Mar-Apr;48(2):59-63.

Destruction of challenged endotoxin in a dry heat oven.

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Ibaraki Plant, Sumitomo Pharmaceuticals Company, Limited, Japan.


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 degrees and 250 degrees 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 degrees and 250 degrees C were fairly close to the predicted values. When the challenged endotoxin was exposed for 60 min in a dry heat oven at 200 degrees 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 degrees 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.

[Indexed for MEDLINE]

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