Reagent Stability Studies

Get confirmation data on how your reagent performs over time, under defined storage conditions.

The flexibility of tailored study designs with the assurance of validated protocols.

Set timepoints that reflect how your product is stored and used.

Evaluate performance under multiple temperature and storage conditions.

Select from a comprehensive suite of analytical and contamination control tests.

QC testing is performed with the same equipment and processes used during manufacturing for a direct match.

Stability studies begin immediately after manufacturing for true timepoint-zero data.

Determine your reagent’s accurate shelf life and assess if it can be safely extended.

The flexibility of tailored study designs with the assurance of validated protocols.

Set timepoints that reflect how your product is stored and used.

Evaluate performance under multiple temperature and storage conditions.

Select from a comprehensive suite of analytical and contamination control tests.

QC testing is performed with the same equipment and processes used during manufacturing for a direct match.

Stability studies begin immediately after manufacturing for true timepoint-zero data.

Determine your reagent’s accurate shelf life and assess if it can be safely extended.

Diagram comparing real-time and accelerated reagent stability testing methods — Real-time testing reflects actual storage conditions, whereas accelerated testing applies controlled stress to evaluate long-term performance sooner.

Stability testing can be performed as real-time or accelerated studies:

Real-time stability studies begin at T0 (baseline) under the product’s typical storage conditions (for example, -20°C, 2-8°C, or room temperature), with testing at scheduled intervals (M1, M3, M6, and so on) through and beyond the intended shelf life. Post-shelf-life timepoints provide the data needed to support expiry date extension.
Accelerated stability studies, on the other hand, use elevated temperature and humidity to simulate long-term aging in a compressed timeframe. Stability under normal conditions is then predicted using the Arrhenius equation:

Accelerated studies are particularly useful for process validation and new reagent qualification, or when regulatory or development timelines can’t wait.

Reagent Stability Studies

Stability Studies Designed to Your Specifications

Customizable timepoint planning

Flexible temperature & storage

Full menu of QC testing

QC integrated with manufacturing

Turnaround time for results

Shelf life determination & extension