Sterility, Endotoxin, Bioburden and Purity Explained
This resource is educational documentation for laboratory procurement and record review. It does not provide medical advice, treatment guidance, dosage, administration, or reconstitution instructions.
Purity describes chemical or chromatographic composition under a stated method. Sterility testing addresses whether viable microorganisms were detected under the test conditions. Endotoxin testing addresses bacterial endotoxin under the selected method. Bioburden describes microbial counts before a sterilizing step or within a defined process.
These measurements are not interchangeable. If a lot has an HPLC result but no sterility or endotoxin record, the documentation should say so directly.
FDA Q7 discusses documented laboratory controls, microbiological testing where specified and certificate content; see the guidance.
Research Use Only. Not for human or animal consumption, diagnostic use, therapeutic use, veterinary use, or clinical application.