Storage stability studies

CLS-logo.png Concept Life Sciences offers GMP pharmaceutical stability studies and ICH storage services to support development, commercial stability studies and sample batch release.

Concept’s stability team designs and delivers GMP stability programs for a comprehensive range of dosage forms, APIs and product types.

We provide efficient study management as well as a range of standard and bespoke storage conditions and testing capabilities to satisfy all regulatory criteria for short-term, real-time, accelerated or forced-degradation study requirements. We deliver data that enables our clients to establish product performance, required storage conditions, retest intervals and product shelf lives.

Our teams have the specialized knowledge required to develop and validate stability indicating methods and perform assay/impurity analysis as well as tests for dissolution, moisture, hardness and disintegration. Physical stability assessments (physical form, polymorph, particle size) are conducted alongside chemical stability determinations.

Our capabilities

We offer a range of storage conditions including climatic chambers, refrigerated as well as frozen storage which are fully controlled and monitored, with back-up generator support.

  • Actives, development formulations, finished products
  • R&D studies (ICH / GMP)
  • Stability-indicating assays, forced degradation
  • Protocol design
  • Sub-sampling and packaging (e.g. heat sealing)
  • Storage (-80ºC to 40ºC/75%RH, Ozone)
  • Analysis (physical / solid state / chemical)
  • Trend analysis
  • Reporting