Storage stability studies
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.
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
Bioanalysis and biomarkers
Cleaning validation and verification
Clinical and commercial manufacturing
Contaminants and foreign bodies
GXP analytical method development, validation and transfer
Out of specification investigations
Process research and development and pre-clinical API manufacture
QC release and GMP release testing