USP <71> Sterility Test
United States Pharmacopeia (USP) <71> sterility testing for sterile dosage forms. Results in a Pass/Fail result, unlike USP <61> for nonsterile dosage forms (tablets/liquids) with a TAMC/TYMC result.
Lead time is 14 - 21 days for incubation and analysis. If the test fails, organism identification is available for an additional charge.
USP <71> recommends a number of vials to test based on batch size. All vials sent are composited and tested as one sample, so there is no additional charge for up to 20 vials:
- Less 100 vials: 10% or four vials, whichever is greater
- Between 100 and 500 vials: 10 vials
- Greater than 500 vials: 20 vials




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USP <71> Sterility Test
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Discover more in our FAQ
What types of samples do you test?
We test a wide range of products including capsules, tablets, powders, liquids, and peptides for potency, sterility, and more.
How long does testing take?
Standard turnaround is 3–5 business days. Rush options are available upon request.
What information should I include with my sample?
Please include the label claim (mg), sample identifier (e.g. cap color or lot number), client name, and tracking number.
Will I receive a Certificate of Analysis (COA)?
Yes, every completed test includes a detailed, lab-verified COA tailored to your product and compliance requirements. COAs are delivered electronically to the email provided at checkout.