PDA Letter Article

PDA Comments: Ph. Eur. Tackles Endotoxin Alternative rFC

by Rebecca Stauffer, PDA

The European Pharmacopeia has proposed a new chapter pertaining to use of recombinant Factor C for the bacterial endotoxin test. Recombinant Factor C (rFC) has been a topic of interest as far as endotoxin testing for awhile. PDA had the opportunity to comment on the proposed chapter and submitted some observations.

The comments can be found here.