Regarding depyrogenation

Dear all,
kindly suggest me why 3 log reduction required for depyrogenting tunnel . what was the retionalle behide that choice ,any reference provided will be appriciable

Here we r spking for 10000eu…In order to depyrogenate…It requires 3log reduction

Check out USP <1211>

http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1211.html

The 3-log reduction is for endotoxin reduction requirements (which is not sterility). Sterility has a different log reduction (also described in the link above)

2 Likes