Do you require stability testing for the registration of a new substance or product? Eos Scientific offers stability testing for a wide range of manufactured and natural products.
Stability testing is used to demonstrate short and long term stability of a biologic or therapeutic after exposure to a variety of environmental factors and is a critical component of product development. Not only do you need to know how long your product will last under normal conditions, but determining how robust your product is under stressed conditions is equally important. When it’s time to bring product to market, release testing becomes increasingly paramount.
We have the expertise to apply stability testing methods to detect compound changes in identity, purity and potency and Our laboratories are well equipped to perform all necessary standard stability studies.
- ICH climate conditions (chambers and cabinets)
- Extractable and Leachable testing
- Forced degradation (including Photo stability testing)
- Holding time studies
- In-use stability testing
- Freeze-thaw stability testing
- Alarmed monitoring systems
- Secured storage areas
- Temperature, humidity, and light variability
- Labelling, handling, and storage
- Computerised entry and reporting
- Long term stability testing
- Accelerated stability testing
- Stress testing – this identifies likely degradation of products and is done on a single batch of drugs. It includes temperature, humidity, oxidation, and photolysis testing.
- Batch selection – data should be provided for at least 3 primary batches
- Container closure system – this should simulate the packaging proposed for storage and distribution
- Specification – testing should cover the physical, chemical, biological, and microbiological attributes. Validated stability indicating analytical procedures should be applied
- Long term studies – depend on the proposed re-test period (every 3 months for the first year, 6 months for the second year)
- Accelerated storage – minimum 3 time points for a 6-month study
- Intermediate storage – minimum 4 time points for a 12-month study (0, 6, 9, 12 months)
- Storage conditions – conditions and length of studies chosen should cover storage, shipment and subsequent use
- Evaluation – usually data is analyzed quantitatively on an attribute that is expected to change over time
- Statements and labeling – this should accord with relevant national/regional requirements. Specific instructions on storage should be provided