Shelf life and stability testing
A stability study is how an expiry date stops being a guess. Samples are stored under controlled conditions, pulled on a schedule, and assayed each time against the day-zero result, so degradation is measured rather than assumed.
- Pricing
- Quote on request
- Family
- Programme
Contact us to confirm the sample matrix, analytical scope and price before shipping.
- Stability chamber, logged
- Agilent 1290 or 6490
- Moisture balance and aw meter
- Incubated plates
Purchased new through authorised channels, performance-qualified by certified engineers, and the instrument ID prints on every certificate. View the bench.
What the panel measures
| Test | Method | Instrument | Reports as |
|---|---|---|---|
| Accelerated storage | Method40 °C / 75% RH, ICH Q1A | InstrumentStability chamber, logged | Reports asPulls at 0, 1, 3 and 6 months |
| Intermediate storage | Method30 °C / 65% RH | InstrumentStability chamber, logged | Reports asPulls at 0, 6 and 12 months |
| Real-time storage | Method25 °C / 60% RH | InstrumentStability chamber, logged | Reports asPulls to 24 months or your claim |
| Potency at each pull | MethodHPLC-UV or LC-MS/MS, same method throughout | InstrumentAgilent 1290 or 6490 | Reports as% of day-zero value |
| Moisture and water activity | MethodLoss on drying and aw | InstrumentMoisture balance and aw meter | Reports as% and aw at each pull |
| Microbial at each pull | MethodUSP <61>/<62> | InstrumentIncubated plates | Reports asCFU/g, TAMC and TYMC |
| Appearance and pH | MethodVisual and electrode | InstrumentDocumented and photographed | Reports asDescribed, with photographs |
Sample requirements and shipping
| Item | Requirement |
|---|---|
| Sample quantity | RequirementEnough for every pull plus two retains. We calculate it from the schedule before you ship. |
| Packaging | RequirementIn the packaging you will actually sell. Stability in a jar says nothing about stability in a sachet. |
| Study design | RequirementTell us the claim you want to support and we write the pull schedule to it. |
| Condition | RequirementShip promptly. The clock starts at receipt and the day-zero assay runs the same week. |
Confirm the scope and quote before shipping. Shipping instructions follow the agreed testing order. We accept no walk-in drop-off, and we hold no DEA registration, so no Schedule I to V material.
Why the method matters
Accelerated conditions give you a signal in six months rather than two years, but the extrapolation is only as good as the design. We write the schedule against the claim you are trying to support and state the assumptions on the report.
The same method has to run at every pull, on the same instrument family, with the same reference standard lot where possible. A method change mid-study makes the trend meaningless, which is why the study record carries the method version for each pull.
What comes back
A public certificate
Every result, the method, the instrument ID, the LOD and LOQ and the signature, verifiable by accession number with no login.
The filmed route
Your package opened on camera, a photograph of each container, and the footage retained for three years. Released to you on request.
A retained sample
Kept about 90 days, so a disputed result can be reviewed and, where warranted, rerun or sent to another laboratory.
Questions about shelf life and stability testing
What does it cost?
Stability-study pricing depends on the duration, storage conditions, analytes and pull schedule. Contact us to confirm the sample matrix, analytical scope and price before shipping.
Can you store the samples?
Yes. Chamber storage, logged continuously, is included in the study fee. The temperature and humidity log is available with the report.
What happens if a pull fails?
We report it and tell you immediately rather than at the end of the study. A failing pull is usually the most useful data point you will get.
Confirm testing scope
Order in the builder, pay, and a prepaid label is emailed to you. The certificate publishes to the database the moment it is signed.