Industry feedback on USP bioreactivity draft monographs

Industry feedback on USP bioreactivity draft monographs

Bioreactivity is a mandatory test for plastics used in the composition of primary packaging for parenterals and implanted devices. It is typically tested using an in vivo test where extracts from the plastic are injected into live animals, or an in vitro test where...
Industry feedback on the bacterial endotoxin test (BET)

Industry feedback on the bacterial endotoxin test (BET)

A USP comparability study of recombinant reagents (recombinant Factor C and recombinant cascade) to lysate reagents The absence of bacterial endotoxins in parenteral products is a key attribute to ensure patient safety. The compendial test described in this USP uses...