We offer a complete range of stability tests for your product, from the classification of samples, through analysis, right up to documentation.
As a one-stop shop for test results, we will save you time and logistics. We can also test samples which have been stored elsewhere.
You can choose the format for handling OOS and OOT results.
Test samples (including pharmaceutical products falling under the Narcotics Act) are stored in monitored, calibrated and qualified climatic chambers or cabinets in line with the applicable ICH stipulations at 25°C / 60% RH, 30°C / 65% RH and 40°C / 75% RH. We can also create customer-tailored storage conditions in line with your specifications.
Our service includes:
- Archiving of samples and documents
- Quantitative analysis of active agents and preservatives
- Determination of purity
- Agent release (profile or limit testing)
- Determination of water content
- Dimensions, compressive strength, mass, deterioration, density, filling volume etc.
- Microbiological testing via a cooperative partner
- ICH-compliant stability testing of proteins and biosimilars