USP <71> is the compendial sterility test for products labeled sterile: injectables, ophthalmics, compounded preparations, and reconstituted peptide products. It runs by membrane filtration or direct inoculation into two media, and it takes 14 days of incubation — that is the method, not our queue. Any lab quoting a 7-day USP <71> sterility result is not running USP <71>.
Sterility cannot be inferred from a bioburden result, an endotoxin result, or a filtration step. It is a distinct compendial test with a defined method and a defined duration. If a product is labeled sterile, this is the test that supports the label.
Anything intended for injection and labeled sterile requires USP <71> support. This includes reconstituted peptide preparations sold or dispensed as sterile.
USP <797> sterile compounding requires sterility testing for preparations exceeding defined beyond-use dating and batch-size thresholds.
USP <71> requires incubation in fluid thioglycollate and soybean–casein digest media for not less than 14 days. Slow-growing organisms are the entire reason the duration exists.
Before the test is valid, the product must be shown not to inhibit microbial growth. Method suitability is run once per product and matrix, and we run it before the first release test.
Bioburden counts what is there. Sterility asks whether anything is there at all. They answer different questions and one does not substitute for the other.
The signed COA references the method, the media, the incubation period, and the sample plan — formatted for inclusion directly in your batch record.
What a USP <71> submission involves:
Submitting takes less than 5 minutes. Most projects turn around in 5–10 business days from sample receipt.
Send a brief project description — sample type, quantity, and timeline. We confirm turnaround and quote within one business day.
We'll send a submission form and our San Diego shipping address. Most samples ship ambient or cold depending on stability requirements.
Results are delivered as a signed PDF COA within the agreed turnaround. Rush service (2–3 business days) is available for urgent timelines.
Send us your samples and receive a signed Certificate of Analysis. Results in 5–10 business days.