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Fill Volume Testing
USP <697> fill-volume verification (container content) for injectable products.
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Compendial standard this method is validated to.
Business days from sample receipt to report.
WHY YOU NEED IT
Why Fill Volume Testing Matters
Deliver the full dose
USP <697> confirms each container holds enough product to withdraw the labeled volume, so the intended dose can actually be administered.
Account for holdback
Product is always left behind in the vial and syringe; deliverable-volume testing verifies the fill accounts for it.
Catch filling errors
Under- or over-filled containers signal a filling problem — measuring content is a direct check on that step.
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. [ not used for lot release]
1-5 vials (depends on volume per vial)
Pharmacy Sample Vials to Test
◦ 10mL: 1 vial
◦ 3-10mL: 3 vials
◦ 3mL: 5 vials
Stability Studies
Across your stability timeline
The same test run at each stability timepoint — for example, to support a longer beyond-use date (BUD).
[X] vials N/A
TECHNOLOGY
Withdraw, measure, compare to label.
01
Withdraw the contents
Product is drawn from the number of containers <697> specifies for the fill size, using a dry syringe and needle.
02
Measure the volume
The contents are measured in a graduated cylinder, or by mass and density for prefilled formats.
03
Compare to label
The deliverable volume is checked against the labeled volume to confirm the full dose can be given.
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
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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>
✓
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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