In the field of stability testing, we offer a comprehensive service for human and veterinary medicinal products as well as for medical devices.
Our service includes consulting and planning of your stability studies as well as all necessary testing and quality assessments. We store your samples at the desired storage conditions (e.g. ICH conditions and special conditions) and take over the complete management of samples, including the analysis of the stability samples at the agreed time.
Our Services in Detail:
- Advice and Assistance in the Planning of Stability Studies
- Development of Stability Plans
- Conducting Stability Studies (Exploratory, Confirmatory, Ongoing, Follow-Up)
- Implementation of Dawn Rates (Freeze-Thaw)
- Stress Tests (Stability Indicating)
- Photostability Testing
- Simulation of Thawing and Freezing Cycles (In-Use)
- Storage of your Samples within the Scope of Stability Testings as well as Intermediate Store in Cases of Capacity Bottlenecks
- Complete Data - and Sample Management including Scheduling and Dispatch of Stability Samples
The storage of your stability samples can be carried out under different climatic conditions:
By default, we store at the following temperature conditions:
- Long-Term: 25°C/60% r.h.
- Intermediate: 30°C/65% r.h.
- Accelerated: 40°C/75% r.h.
- Fridge/Freezer: 5°C/-20°C/-80°C
We also offer customers a wide range of specific storage conditions. Especially for producers of medicinal devices we are offering qualified, walkable climate chambers to store even products with large volumes at 55°C.
In all cases, the monitoring of storage conditions is controlled by
- Online Monitoring
- Daily Manual Control of the Monitoring System
- Alarm System via Telecommunications Services (SMS)
As a specialty, we offer the testing on photostability of active ingredients and finished products.
We offer the test for photostability
In addition to our comprehensive services regarding stability testing and storage, we offer the test for photostability according to guideline ICH Q1B "Stability Testing: Photostability Testing of New Drug Substances and Products".
Equipment, Methods, Procedures
- Temperature- and Moisture-Regulated Photostability Chambers
- The Endpoint Detection is Performed with Calibrated Sensors
- Finished Pharmaceutical Preparations
- Primary Packed Products
- Analysis of the Unexposed and the Exposed Sample
- Analysis of Reference Samples
- Determination the Physical Properties - Assay
- Detection and Analysis of Degradation Products
- Dissolution / Drug release
- UV (300-400 nm): At least 100 Wh/m²
- VIS (400-800 nm): At least 1.2 million lx
The light intensity and temperature during the tests are measured on the surface of the sample.