ICH Stability Studies
Reliable Stability Testing Aligned with ICH Q1 Guidelines
Storage stability studies are a key part of the development of many product types, investigating the ability of the product or material to retain specified physical, chemical and performance attributes and hence quality / efficacy, under the influence of a wide range of environmental conditions such as temperature, humidity, light, or agitation.
Whether it’s a R&D study investigating drug substance degradation, a medium-term study establishing acceptable packaging configurations, or an ICH Q1 compliant 3-year study supporting product shelf-life, Cormica can support you.
Our unique blend of spectroscopic, chromatographic, solid state elemental and microbiological analysis, combined with GMP-validated reach in stability rooms, allows us to provide a comprehensive in-house solution for your storage stability study needs.
Types of Study
Real Time & Accelerated Studies
R&D Assessments
Degradation / Aging Studies
Packaging Studies
Shelf Life Studies
Workflow
Protocol Design
Sub-Sampling & Set Down
Wide Range of Storage Conditions
24/7 Monitoring; Backup Generator
Chemical, Physical & Microbial Testing
Trending & Reporting
Sample Types
Raw Materials / Critical Excipients
Controlled Substances
Active Ingredients / Drug Substance
Formulations
Finished Product / Drug Product
Wide Range of Dosage Forms
Testing
R&D Methods
Limit Tests
Quantiative Methods
Chemical Stability
Physical Stability
Microbiology / Performance Testing
Laboratories near you, supporting global product success
With accredited laboratories in the UK, EU and US, we support pharmaceutical, medical device and combination product manufacturers worldwide. Local support combined with global quality, delivered by teams who understand your regulatory requirements.
Cormica’s stability team provide efficient study design and 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, intermediate, 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 specialised 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 (water content, physical form, polymorph, particle size) are conducted alongside chemical stability determinations.
We offer a wide range of standard and bespoke storage conditions including reach in rooms, climatic chambers, refrigerated as well as frozen storage, all of which is monitored by our fully-validated, compliant Environmental Monitoring System. Our facility is complete with back-up generator support. All chambers are restricted access.
- Storage Conditions from -80 °C freezer to 40 °C / 75 % RH, including:
- 25 °C / 60 % RH, Real time storage condition
- 30 °C / 65 % RH, Intermediate storage condition
- 40 °C / 75 % RH, Accelerated storage condition
- Designs from short-term R&D assessments to ICH Q1 compliant shelf life studies
- Study durations of a few days / weeks to multiple years
- Protocol design
- Sub-sampling, complex packaging configurations, labelling and set-down
- Trend analysis
- Range of reporting options
- Generator backup and 24/7 temperature / humidity monitoring
Chemical Stability
Including active ingredient content, stability-indicating assays and forced degradation.
Physical Stability
Including appearance, volatiles / moisture content, mass loss, solid form / polymorphism, and particle size / surface area.
Microbiological Testing
Including Absence of Specified Organisms & Pathogens, TAMC / TYMC, Microbial Limits Testing.
Physical Product Testing
Including device validation & verification, ageing, transit and transportation studies.