A vial can be 99.4 per cent pure and not sterile in the same afternoon
Every certificate circulating in this market answers a question about molecules. Almost none answers a question about organisms, pyrogens, or the integrity of the seal.
Endotoxin
Page 5 of 5 of this archive, newest first.
Low endotoxin recovery: the interference nobody looks for
We submitted vials for endotoxin determination and report the results, the method and the laboratory, because a pyrogen figure without a method is as empty as a purity…
Two documents, two disciplines: purity and sterility are not the same trade
Every certificate circulating in this market answers a question about molecules. Almost none answers a question about organisms, pyrogens, or the integrity of the seal.
How to read the silence on a certificate you already hold
Our position is about documentation practice. It is not an allegation about anybody’s honesty, and we are explicit about the difference.