Stability and QC testing services to meet ICH guidelines and support every stage of drug development
Comprehensive testing for both drug substance and drug product, including radiolabelled compounds and controlled substances
Seamless coordination across PR&D, analytical and GMP teams to accelerate timelines and ensure consistent product quality
A full suite of ICH stability & QC testing capabilities
We offer comprehensive testing services for both drug substance and drug product – including radiolabelled compounds and controlled substances.
- Stability-indicating assays and related substances
- Stability and photostability testing (ICH Q1)
- QC Raw material, intermediate and release testing
- Reference standard certification
- In-process controls
- Cleaning verification
- Particulate matter and sub-visible particle testing
- Dissolution testing
- Radiochemical purity analysis
- Specific activity (LSC)
- Sub visible particles
- Osmolarity testing
- Packaging component evaluation
Advanced equipment to deliver fast, accurate, and compliant results:
- HPLC/UHPLC with UV
- DAD / CAD
- Conductivity, fluorescence and radiochemical capabilities
- Structure confirmation by NMR
- KF moisture determination
- GC analysis
- Elemental impurity analysis (ICH Q3) –
- ICP-MS
- Residue On Ignition (ROI)
- IR spectroscopy
- Liquid Scintillation Counter (LSC) | FTIR | UV
Arcinova: Your stability study is safe in our hands
Deep expertise across our integrated teams
- Integrated services within a CMC programme
- Standalone third-party analysis, with specialist expertise available through our radiochemistry team
ICH-compliant facilities to support your needs
Our stability services are supported by facilities that have ICH-compliant stability chambers, reach-in units, and photostability testing equipment to assess the effects of light stress on materials and packaging.
We accommodate a range of study durations:
- Short-term assessments
- Multi-year programmes
- Flexible options for storage only
- Storage and test packages to suit your specific requirements
Partnership for the lifecycle of your studies
From sample set-down to final reporting, we look to ensure every detail is right–from labelling and pack orientation, to storage conditions and testing timelines.
- Stability protocols are developed through clear consultation
- Support for method optimisation or qualification to ensure testing is tailored to your material
- Reporting managed through our Quality Management System (QMS), with full visibility for client review and approval at every stage
Avoid delays with a trusted partner in stability and QC testing
Our approach is built on delivering reliable, regulatory-ready data to support shelf-life, re-test dates and expiration date assignments across all clinical phases. No matter the stage of development, our team provides expert guidance and robust testing to keep your programme on track.
Stability protocols are generated as part of every study we manage, ensuring full alignment with your development goals and regulatory requirements. Our systems ensure complete traceability – from sample receipt and stability storage through to time-point testing and final reporting.
With capacity to handle cytotoxic, radiolabelled and controlled substances, we’re trusted by clients across the sector as a partner for complex stability programmes.
