We carry out long-term, short-term and ongoing stability storage of finished pharmaceutical products and active substances in accordance with current ICH guidelines and GMP requirements.
Stability testing is used to determine and verify the chemical and physical durability of pharmaceuticals under certain storage conditions at a specific humidity and temperature. Such tests are essential in pharmaceutical development, authorisation and registration in order to define and verify shelf life.
All pharmaceuticals available on the market must also undergo continuous stability testing to prove their durability.
Stability storage and
We carry out long-term, short-term and ongoing stability storage of finished pharmaceutical products and active substances in accordance with current ICH guidelines and GMP requirements. Clients engage us to test storage and in-use stability, monitor batches on the market (ongoing stability) and test durability in connection with variations.
After the storage period is completed, our analysts set to work according to the stability testing plan or the client’s specifications. We test all forms used for administering pharmaceuticals – from solid forms such as tablets and capsules and semi-solid forms such as creams and ointments through to liquids.
Standardised processes for reliable stability testing:
- Testing plans that meet regulatory requirements
- Narcotic drugs licence in accordance with Section 3 of the German Narcotic Drugs Act (BtMG)
- Import licence for international projects
- Storage in accordance with ICH conditions
- Coordination, analysis, assessment and reports
- Efficient planning and implementation of ongoing stability tests
Our climate cabinets represent all standardised climate conditions and enable reliable and efficient stability storage.
- Climatic zone II (25°C/60% RH)
- Intermediate condition, climatic zone IVa (30°C/65% RH)
- Accelerated condition (40°C/75% RH)
Special climatic zones
- Climatic zone IVb, (30°C/75% RH)
Cold and frozen storage
- 2°C to 8°C