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Stability Programs

A shelf life is a study, not a guess.

Beyond-use dates and shelf lives hold up when there is a protocol, a chamber, a pull schedule and a data set behind them. We run the study end to end, so your dating is something you can hand to an inspector.

ICH Q1A(R2)USP <1150>USP <797>
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Designed around the claim you want to make

The protocol comes before the chamber. What are you claiming — a longer beyond-use date for a compounded preparation, a supported shelf life for a finished product, a bracketed claim across several strengths? That answer sets the conditions, the time points, the container-closure orientations and the test panel. Getting it right at the design stage is the difference between a study that supports the claim and twenty-four months of data that does not quite fit it.

Conditions, pulls and custody

Samples sit under monitored, alarmed storage from intake onward, with chain of custody recorded at every handoff. We hold the pull schedule and pull on it — you are not managing calendar reminders for a thirty-six-month study. Each time point is tested and reported as it completes rather than saved for a single report at the end, so a drift is visible while you can still act on it.

  • Long-term 25 °C / 60 % RH and intermediate 30 °C / 65 % RH
  • Accelerated 40 °C / 75 % RH for early signal and supporting data
  • Refrigerated and frozen conditions for products that require them
  • Time points at 0, 3, 6, 9, 12, 18, 24 and 36 months, or a schedule built for your claim

What you get back

  • A written stability protocol covering conditions, time points, orientations and the test panel
  • Storage under monitored, alarmed conditions with chain of custody from intake
  • A report at each time point as it completes, not one report at the end
  • A final stability summary tying the data to the shelf life or beyond-use date claimed
  • The supporting file a USP <797> beyond-use date extension needs
What's included

The scope of stability studies.

ICH storage conditions

Long-term, intermediate and accelerated conditions, plus refrigerated and frozen where required.

Protocol design

Time points, conditions, container orientation and test panel built around your product and its claim.

Managed pull schedule

We track every time point and pull on schedule — no calendar reminders on your side.

Microbiological time points

Sterility, bioburden or microbial limits at each pull, depending on the product.

Custody & monitored storage

Chain of custody from intake, with samples held under alarmed, monitored conditions.

Beyond-use dating support

Data packaged to support USP <797> and <795> beyond-use date extensions.

Common questions

Stability Studies, answered.

How long does a stability study take?
As long as the claim you are supporting. An accelerated study at 40 °C / 75 % RH runs three to six months and gives an early signal plus supporting data. A long-term study runs the full period you intend to claim — twenty-four or thirty-six months — with pulls along the way. Most programs run both in parallel so there is data to work with early and data to stand on later.
Can a stability study support a longer beyond-use date?
Yes, and for compounding pharmacies that is usually the reason to start one. USP <797> allows a beyond-use date to be extended when it is supported by a documented stability study on the preparation as you actually compound it, in the container you actually use, under the storage condition you actually claim. A study on a published analogue will not carry the extension — it has to be your preparation.
How many units do I need to supply?
Units per time point, multiplied by time points, multiplied by conditions, plus retains for repeat or investigational testing. A modest protocol can still come to more units than people expect, which is why we calculate it with you during protocol design rather than after you have compounded the batch.
Does the study cover chemical assay as well as microbiology?
Our stability programs cover the microbiological attributes — sterility, bioburden and microbial limits at each time point, depending on whether the product is sterile. If your claim also needs potency or impurity data, say so at protocol design and we will scope the study so both sets of data run on one schedule and one set of pulls, rather than duplicating the program.
What storage conditions can you hold samples at?
The ICH conditions — long-term 25 °C / 60 % RH, intermediate 30 °C / 65 % RH and accelerated 40 °C / 75 % RH — plus refrigerated and frozen storage for products that require them. All conditions are continuously monitored and alarmed, and the monitoring record forms part of the study file.
Often run together

Related testing.

Sterility Testing

Membrane filtration or direct inoculation under USP <71>, with the bacteriostasis and fungistasis suitability work that has to come first.

USP <71>

Bioburden Testing

Total aerobic microbial count and total yeast and mold count on raw materials, in-process samples, water and finished units — the number your sterilization cycle is validated against.

USP <61>ISO 11737-1

Microbial Limits Testing

Enumeration under USP <61> and tests for specified microorganisms under USP <62> — the pair that releases a non-sterile product.

USP <61>USP <62>USP <1111>

Ready to scope your stability studies?

Send us the product and the claim you need to support. We'll confirm the method, the sample count and the turnaround before anything ships.

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