How Do Endotoxins End Up in Peptides? What about Sterility?
This is one of those things that sounds scary at first, but once you understand it, it actually makes a lot more sense. π€·π»ββοΈ Testing for endotoxins and sterility has become all the rage in the research peptide world, but is it really a dealbreaker - or some fear mongering for marketing advantage? You decide! βοΈ Endotoxin vs. Sterility Tests β‘ Sterility tests fail more often and up to a point that should be more troubling than the presence of endotoxins because non-sterility means there is bacterial contamination. β‘ Typically a sterility test fails if you go for 21+ days. Therefore best practice is to limit the time to use up a research peptide vial and use BAC water to prevent bacterial growth. However, BAC water will not kill bacteria already present it only inhibits growth. β‘ For endotoxin, there are a few scary stories out there. The pass/fail for peptides per vial is 40EU. Now drop that to dosage, and most vials, even at max allowance, will see less than 10EU per dose. β‘ BUT if you're getting an IV at a clinic, that has an allowance of 175EU... in a single dose. β‘ For subcutaneous injections sterility is less of a concern. Getting a cut or scratch with dirt carries far more bacteria than could be found in a lyophilized vial, even ones that flagrantly fail sterility. βοΈ Sterility is when there is no bacteria present in an environment. This test actually requires a minimum of 2 weeks for proper development and specialized equipment, a simple pass/fail test is not a good marker for sterility. βοΈ An endotoxin is not bacteria itself. It's a toxic fragment from the outer wall of certain bacteria (called Gram-negative bacteria). When those bacteria break apart, they release a molecule called lipopolysaccharide (LPS). ππΌ Your immune system reacts very strongly to LPS because itβs basically a signal that harmful bacteria were present. ππΌ So the real question is: how does something like that end up in a peptide vial? Here are the most common ways... 1. Water systems