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Compendial Sterility Testing
The traditional USP <71> sterility method, accepted by every regulatory body.
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Compendial standard this method is validated to.
Calendar days from sample receipt to report.
Compounded formulations supported to date.
WHY YOU NEED IT
Why Compendial Sterility Testing Matters
The accepted ‘referee’ test
USP <71> is the compendial reference for sterility — a passing result is the universally recognized basis for releasing a sterile product.
Broad organism recovery
A 14-day incubation across two growth media (TSB and FTM) is designed to recover slow-growing bacteria and fungi.
What inspectors expect
For products and programs that require the compendial method, <71> is the test regulators and inspectors look for.
OUR PROCESS
How we run this test for you
Method Suitability
Proving the method first
Before any lot release, we validate that the test method performs reliably for your product — the compliance step that comes first.
Typically 40 vials per study
Lot Release
Releasing every batch
Our core service — we run the test on each lot so you can release the batch to patients with confidence.
Typically 10 vials per lot
Stability Studies
Across your stability timeline
The same test run at each stability timepoint — for example, to support a longer beyond-use date (BUD).
40 vials for MST, then 10 vials per timepoint
TECHNOLOGY
Filter, culture, and watch for 14 days.
01
Membrane filtration
Product is filtered through a sterilizing-grade membrane that captures any microorganisms, then rinsed free of residual product.
02
Dual-media incubation
The membrane is cultured for 14 days in both FTM and TSB media to recover aerobic and anaerobic bacteria and fungi.
03
Compliant reporting
NGS technologies are used to identify the microbial species and provide compliance support (if applicable)
OUR SERVICES
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STABILITY STUDIES
Planning a stability study?
See how this test can support a validated stability program and the data needed for extended beyond-use dating.
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Stability-indicating HPLC methods that separate API from degradation products
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Custom study designs for refrigerated, frozen and room-temperature storage conditions
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Defined pull points with potency, pH, appearance and container-closure assessment
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Documentation packages to support extended beyond-use dating under USP <797>
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Sterility and endotoxin testing integrated at study end points
Guide: USP <797> stability studies & extended beyond-use dating →
Request a Stability Study Quote
Starting at $10,000
CATEGORY 2
CATEGORY 3
These studies generate the stability data required to qualify for the extended beyond-use dates that USP <797> permits for Category 2 and Category 3 CSPs — going well beyond the default short-dating limits.
TYPICAL STUDY OUTLINE
What a stability program covers
Supports
USP <797> Cat 2 & Cat 3 extended BUD
Storage conditions
Refrigerated · Frozen · Controlled RT
Pull points
T0, then defined intervals to BUD
Assays per point
Potency · pH · Appearance
Method type
Stability-indicating HPLC
End-point testing
Sterility · Endotoxin
Deliverable
BUD support documentation
COMMON QUESTIONS
Frequently Asked Questions
RELATED INFO
Relevant Resources
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TALK TO A SCIENTIST
Tell us what you need tested
Whether you need testing guidance, a quote, or just have questions — we’re here. A scientist will follow up within one business day.
USP methods verified for suitability, alternatives validated
Response within one business day
No obligation — guidance and quotes welcome
For service requests, quotes, or technical questions, email our support team.
info@saphobio.com
Phone
Available Monday to Friday, 9:00 AM – 6:00 PM (Pacific Time).
Text us: +1 (929) 437-6148
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1068 Washington St Ste B, San Carlos, CA 94070
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