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Particle Counting

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

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Compendial standard this method is validated to.

TAT

Business days from sample receipt to report.

Compounded formulations supported to date.

WHY YOU NEED IT

Why Particle Counting Matters

Detect what the eye can't

USP <788> counts sub-visible particles down to 10 and 25 µm — too small to see, but still a patient risk.

Limit the particle load

Sub-visible particulates are linked to vascular and immune reactions; <788> holds product to defined per-container limits.

Objective, numeric data

Light-obscuration counting gives quantitative particle results instead of a subjective pass/fail judgment.

OUR PROCESS

How we run this test for you

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

Counting particles too small to see.

Prepare and degas

The sample is mixed and degassed so air bubbles aren't miscounted as particles.

Light-obscuration count

The sample passes through a light-obscuration sensor that counts and sizes particles at the ≥10 µm and ≥25 µm thresholds.

Average and compare

Replicate runs are averaged and the per-container counts are compared to the <788> limits.

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.

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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

Potency Testing

HPLC potency testing that confirms each compounded lot falls within ±10% of its label claim.

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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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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