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Potency Testing
HPLC potency testing that confirms each compounded lot falls within ±10% of its label claim.
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Compendial standard this method is validated to.
Business days from sample receipt to report.
Compounded formulations supported to date.
WHY YOU NEED IT
Why Potency Testing Matters
Confirm the labeled dose
Potency testing verifies the active ingredient is present at the labeled strength, so patients get the intended dose — not a sub- or super-potent one.
Catch preparation errors
Compounding and dilution steps can introduce errors; an independent assay confirms the finished preparation matches its label.
Back your dating
Tracking potency over time gives a defensible basis for the beyond-use date instead of a conservative default.
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 1 vial 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 1 vial 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).
1 vial per timepoint
TECHNOLOGY
HPLC, measured against a reference.
01
Reference standard curve
A calibration curve from a characterized reference standard ties instrument response to a known concentration.
02
HPLC separation
The sample is separated by HPLC so the active ingredient is measured apart from excipients and degradants.
03
Percent of label
The result is expressed as a percentage of labeled strength and checked against the acceptance range.
OUR SERVICES
Learn About Other Services
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.
✓
Stability-indicating HPLC methods that separate API from degradation products
✓
Custom study designs for refrigerated, frozen and room-temperature storage conditions
✓
Defined pull points with potency, pH, appearance and container-closure assessment
✓
Documentation packages to support extended beyond-use dating under USP <797>
✓
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
Site Visit
Visits by appointment only. Please contact us to schedule.
1068 Washington St. STE B, San Carlos, CA 94070
1068 Washington St Ste B, San Carlos, CA 94070
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