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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.

Compendial standard this method is validated to.

TAT

Business days from sample receipt to report.

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. || Needs revision - per container limits and per size limits are the driving force || particles/volume limit goes down as volume goes up

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

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. ||||| very good for formulation development, useful for checking for aggregates

0 vials / 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.

N/A

Stability Studies

Across your stability timeline

The same test run at each stability timepoint — for example, to support a longer beyond-use date (BUD).

10 vials if fill volume is less than 25 mL. || or 25 ml worth of material ||| 25 ml is min.

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.

Targets RNA from living bacteria and fungi , a direct indicator of active contamination.

OUR SERVICES

Learn About Other Services

2 business days

USP <1223>

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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2 business days

USP <1223>

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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2 business days

USP <85>

Endotoxin Testing

USP <85> bacterial endotoxin testing (LAL) for compounding pharmacies lot release.

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2 business days

USP <85>

Endotoxin Testing

USP <85> bacterial endotoxin testing (LAL) for compounding pharmacies lot release.

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2 business days

USP <621>

Potency Testing

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

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2 business days

USP <621>

Potency Testing

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

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2 business days

USP <1207>

Container Closure Integrity Testing

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

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2 business days

USP <1207>

Container Closure Integrity Testing

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

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18 calendar days

USP <71>

Compendial Sterility Testing

The traditional USP <71> sterility method, accepted by every regulatory body.

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18 calendar days

USP <71>

Compendial Sterility Testing

The traditional USP <71> sterility method, accepted by every regulatory body.

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30 business days

USP <51>

Antimicrobial Effectiveness Testing

USP ⟨51⟩ antimicrobial effectiveness (preservative) testing for multi-dose products.

30 business days

USP <51>

Antimicrobial Effectiveness Testing

USP ⟨51⟩ antimicrobial effectiveness (preservative) testing for multi-dose products.

2 business days

USP <790>

Visual Inspection

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

2 business days

USP <790>

Visual Inspection

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

2 business days

USP <697>

Fill Volume Testing

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

2 business days

USP <697>

Fill Volume Testing

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

2 business days

USP <791>

pH Testing

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

2 business days

USP <791>

pH Testing

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

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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