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pH Testing
pH testing under USP <791> — a fast, low-touch check on each compounded lot.
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Compendial standard this method is validated to.
Business days from sample receipt to report.
WHY YOU NEED IT
Why pH Testing Matters
Protect stability
A preparation's pH strongly affects how fast the active ingredient degrades; USP <791> testing confirms it sits in the intended range.
Comfort and tolerability
Out-of-range pH can cause pain or irritation at the injection site — a quick measurement catches it before release.
Fast and low-touch - DELETE
pH is a rapid check routinely expected as part of releasing many compounded preparations. (pH testing is destructive) - DELETE
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.
N/A
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.
1-2 vials (depends on volume per vial)
> 2mLs
Stability Studies
Across your stability timeline
The same test run at each stability timepoint — for example, to support a longer beyond-use date (BUD).
1-2 vials (depends on volume per vial)
> 2mLs
TECHNOLOGY
A calibrated, temperature-controlled reading.
01
Calibrate with buffers
The meter is calibrated with NIST standard buffers bracketing the expected range before any sample is read.
02
Measure at temperature
The electrode reads the preparation, accounting for the effect of temperature on the pH.
03
Compare to spec
We report the pH and temperature to you, allowing you to check against the expected value
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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