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Release and stability

Release and stability services

Corealis provides comprehensive analytical method development and qualification, release testing, stability and storage analysis services for pharmaceutical oral solid dosage (OSD) drug product formulation development and clinical supplies manufacturing.

Analytical services available from Corealis for OSD drug product formulation development and clinical supplies include:

  • Analytical method development
  • Analysis of prototype formulations
  • Stability storage and testing of prototype formulations
  • Analytical method qualification for release testing as per cGMP requirements
  • cGMP release testing
  • cGMP stability storage and testing
  • Analytical methods validation for manufacturing cleaning verification
  • cGMP analysis for cleaning verification
  • Analytical methods transfer to a sponsor-approved cGMP laboratory

Learn more about release and stability

The team is available to answer any questions about release and stability and a wider range of topics.

Clinical supplies

For clinical supplies, Corealis’ analytical methods always follow the International Council on Harmonisation (ICH) for the current Good Manufacturing Practices (cGMP) guidelines for qualification, release testing, stability and storage analysis. Whatever the project, the team meets the country-specific regulatory requirements.

The most common cGMP analyses executed are:

  • Assays
  • Impurities (related substances)
  • Content and blend uniformity
  • Dissolution (UV, HPLC)
  • X-ray powder diffraction (XRPD)
  • Microbial limit testing
  • Cleaning verification of manufacturing equipment

Contact Corealis

Corealis’ experts are ready to answer any queries about the company’s oral solid dose offering, including its development and manufacturing capabilities.