The Diapharm Analytics service laboratory assists manufacturers from initial pharmaceutical development and the stability testing of bulk or final products through to in-use stability studies, stability monitoring of post-marketing batches (on-going stability testing) and testing in connection with variations.
Diapharm Analytics’ services
- Regulation-compliant testing plans
- Import authorisation for international projects
- Storage according to ICH conditions
- Coordination, analysis, evaluation and reporting
- Efficient planning and implementation of on-going stability studies
- QP interpretation of OOx results (OOS, OOT, OOE)
Stability testing is required in order to determine and validate the chemical and physical shelf-life under specific storage conditions (humidity, temperature). In the run-up to clinical studies, stability testing is used to ensure that the shelf life of a study drug is sufficient to last for the duration of the study. Long-term studies involving the finished product are required for marketing authorisation. Following this, manufacturers are legally obliged to undertake on-going stability studies on a regular basis, so that they are able to prove that the medicinal product in question can be used safely over the entire period of its shelf life.
ICH climactic zones for stability testing
- Climatic zone II, 25°C/60% RH
- Intermediate conditions, 30°C/65% RH
- Accelerated testing, 40°C/75% RH
Special climactic zones
- Climactic zone I, 21°C/45% RH
- Climactic zone III, 30°C/35% RH
- Climactic zone IVa, 30°C/70% RH
- Climactic zone IVb, 30°C/75% RH
- 2°C to 8°C
No lifecycle without stability testing! The “expiry date” of a medicinal product not only supports the safe use of this product, but it can also open up new markets, for example, creating overseas opportunities.