Stability Testing and Storage

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)
  • Placebos
  • 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
  • Photostability
  • 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.