Customized, complete ICH stability storage services
Pace Analytical Life Sciences (PLS) provides secure long- and short-term (accelerated) storage and stability testing to support your cGMP stability programs. We offer a broad range of conditions—temperature only, temperature and humidity, photostability, cycling and freeze/thaw—that supports ICH guidelines.
Custom storage conditions are available to support your specific procedures and timelines—whether you require storage only, storage and testing, testing only, and/or project management assistance. Plus, stability reports can be tailored to meet your needs.
Stability storage/shelf-life study services support R&D and commercial products, including drug substances.
- Active Pharmaceutical Ingredients (APIs)
- Drug products (finished goods)
- Controlled substances (or highly potent compounds)
- Comparative drug products
- Re-current sample storage
PLS has expertise and ready capacity to support multi-packaged registrational stability studies as well as on-going marketed product stability studies.
Available stability services include:
- Protocol writing
- Long-term stability
- Drug-substance stability testing
- Accelerated stability
- Comparative stability
- Forced degradation studies
- Formulation evaluation stability testing
- Temperature testing
- Expedited Analytical Method Transfer
- Stability-Indicating Method Validation Services
See a full list of available Stability Testing and Storage Conditions.
Download Stability Storage and Testing literature.