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.
TrustPointe sterility testing is done using closed-system transfer in an ISO Class 5 Laminar Flow Hood to eliminate laboratory contamination of sterile samples during testing. The vials are never opened, and all of the sampling work is done in a hood designed to prevent microbial contamination.
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
Validated Method
Custom Sample Intake Forms
Flexible Pricing Structure
Secure COA Delivery
Please read and agree to our Terms of Service before placing your order.
USP <71> Sterility Test
Why Choose Us?
What People Are Saying
⭐ Exceptional Accuracy and Service
"We’ve used TrustPointe for over a year now. Their precision and turnaround time are unmatched in the industry."
— Emily R.
⭐ Reliable COAs Every Time
"As a supplement manufacturer, we rely heavily on TrustPointe’s consistency. The COAs are clear, detailed, and always on time."
— Jason M.
⭐ Fast Turnaround, Even on Rush Orders
"We needed urgent peptide testing, and they delivered results within 24 hours. Super responsive team."
— Dr. Lina K.
Great Communication and Support
"They helped us understand the sample submission process and answered all our technical questions. Highly recommend."
— Marcus D.
Our Go-To Testing Lab
"We’ve worked with other labs, but Trust Pointe is our preferred partner — professional, accurate, and dependable."
— Sarah L.
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.