Stability Studies
Comprehensive service
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.
- Storage of your samples under the required conditions (e.g. ICH conditions and special conditions)
- Stability study sample management
- Perform the pre-planned analyses on stability samples as scheduled
Our Services in Detail:
- Preparation and forwarding of storage protocols (storage summary) after recording the samples in the LIMS - Transparency regarding storage and retrieval times
- Storage of your samples as part of stability studies with GMP monitoring
o Technical studies
o Development studies
o Follow-up
o ICH-studies
o On-going studies
o Simulation of in-use Studien - Stability protocol
o Consulting and Assistance in the Planning of Stability Studies
o Implementation and realisation of submitted stability plans - Outsourcing at the agreed time
- Subsequent analyses and submission of results
- Automatic shipping of stability samples
- Transport studies / freeze-thaw / cycle test
- Stress tests Stability indicators
o Photostability testing
o Thermal stress
o Acid or alkaline stress
o Oxidative or reductive stressing - Interim storage in case of capacity bottlenecks and as a backup if your chambers fail
- Storage and shipping of samples possible without analytical services
Your stability samples can be stored under various climatic conditions:
As standard, we store in the following climatic 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
- Desired storage condition not included? We are happy to check the feasibility on our variably adjustable devices.
Your samples are in good hands with us. The storage conditions are monitored 24/7. We have decades of experience in performing stability studies.
- Online monitoring
- Automated alerting
- LIMS module for stability studies with automated reminder to pull samples
- Staff specifically trained to manage stability studies
- Restricted access to stability chambers for trained personnel only
Storage capacity
- approx. 300 m³
Photostability
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
Equipment
- Temperature- and Moisture-Regulated Photostability Chambers
- The Endpoint Detection is Performed with Calibrated Sensors
We analyze
- Drugs
- Finished Pharmaceutical Preparations
- Primary Packed Products
- Cosmetics
Analysis
- 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
Dose
- 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.
