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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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TAT

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 strength 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).

Usually [X] vials per timepoint

TECHNOLOGY

HPLC, measured against a reference.

Reference standard curve

A calibration curve from a characterized reference standard ties instrument response to a known concentration.

HPLC separation

The sample is separated by HPLC so the active ingredient is measured apart from excipients and degradants.

Percent of label

The result is expressed as a percentage of labeled strength and checked against the acceptance range.

Other services

2 business days

Rapid Sterility Testing

Rapid sterility testing validated under USP <1223> — for compounding pharmacies that can’t afford a two-week wait on batch release.

Learn more →

15 calendar days

Compendial Sterility Testing

The traditional gold-standard sterility method, accepted by every regulatory body.

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2 business days

Endotoxin Testing

USP <85> bacterial endotoxin testing (LAL) for patient-safety release.

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2 business days

pH Testing

pH testing under USP <791> — a fast, low-touch check on each compounded lot.

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2 business days

Fill Volume Testing

USP <697> fill-volume verification (container content) for injectable products.

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2 business days

Visual Inspection

USP <790> inspection for visible particulates in injectable products.

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3 business days

Container Closure Integrity Testing

USP <1207> container closure integrity testing (vacuum decay) for sterile vials.

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2 business days

Particle Counting

USP <788> sub-visible particulate matter counting for injectable products.

Learn more →

Antimicrobial Effectiveness Test USP <51>

30 business days

Antimicrobial Effectiveness Testing

USP <51> antimicrobial effectiveness (preservative) testing for multi-dose products.

Learn more →

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-compliant, validated methods

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