USP <71> and USP <85> Testing for Exosome Material — What You Need to Know
The two most important quality tests for exosome material explained: what they are, what the results mean, and why you should see them on every COA.
USP <71>: Sterility Testing
The USP <71> sterility test is a 14-day incubation assay that confirms the absence of viable microorganisms. The test takes two weeks because slow-growing organisms (like certain fungi and anaerobic bacteria) need time to become detectable. Any test reporting sterility results in under 14 days is not a true USP <71> test.
What the result should say: "No growth detected" or "Sterile" with the incubation period and testing method specified.
USP <85>: Endotoxin Testing
The USP <85> bacterial endotoxins test (also known as the LAL test) measures the concentration of endotoxins — fragments of bacterial cell walls that can trigger inflammatory responses in patients. Results are reported in Endotoxin Units per milliliter (EU/mL).
What the result should say: A specific numerical value. The acceptable threshold for biologic material is typically <5 EU/mL. "Pass" or "Compliant" without a number means the actual result wasn't publishable.
Why Both Matter for Exosome Material
Exosome material is administered topically or applied to compromised tissue. Without confirmed sterility and low endotoxin levels, you're introducing unknown biological risk into your protocols. A complete COA includes both USP <71> and USP <85> results from an accredited testing laboratory.