Stability Testing and Storage
In the field of stability testing, we offer a comprehensive service for human and veterinary medicine.
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)
- Implementation of dawn rates (in-use)
- Stress tests (stability indicating)
- Photostability testing
- Simulation of thawing and freezing cycles (in-use)
- Storage of your samples
- 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 climatic zones:
- Climate II: 25°C/60% r.h.
- Accelerated: 30°C/65% r.h.
- Stress Tests: 40°C/75% r.h.
- Cold chain: 5°C/-20°C
- Freezing: -70°C
We also offer customers a wide range of specific storage conditions.
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)
Storage capacity
We have extensive warehouse space for all of the above mentioned climate zones and can offer the temporarily storage of your stability samples for an agreed period of time, if you are dealing with capacity constraints.
As a specialty, we offer the testing on photostability of active ingredients and finished products.
We will be happy to advise you individually on request.
Phytos
Labor für Analytik von Arzneimitteln GmbH & Co. KG
Leibnizstrasse 9 | 89231 Neu-Ulm
Phone +49 (0)731/9 74 39-0 | Fax +49 (0)731/9 74 39-30