Analytical Solutions for Pharmaceuticals and Medical Devices
Analytical solutions and Consultancy services to meet the complex needs of the pharmaceutical and medical device industries.
Intertek Expert Services support release testing of pharmaceutical and medical device raw materials and final products including:
- Raw Material Assay
- Impurities, including trace contaminants (nitrosamines, aromatic amines, dioxins, etc.)
- Residual solvents
- Microbiology
Method development and validation services are provided according to ICH guidelines, as well as method optimization services. Qualification of Reference Materials is available.
R&D Support:
- Structure elucidation including assignment or prediction of complex molecules
- Identification and quantitation of transformation or degradation products
- Characterization of complex formulations
- Failure analysis
Stability Testing:
- Storage according to ICH guidelines
- Analytical testing
- Identification of transformation or breakdown products
- On-line kinetic measurements
Extractables and leachables studies for medical devices:
- Leachability or migration studies
- Identification and quantitation of extractables and leachables
- Determination of the role of additives in polymer formulations
- Recommendations for alternative stabilizers to achieve lower leachability
- Formulation of polymer test samples to evaluate potential leachables
Pharmaceutical Services:
Request more information to see how Intertek can help your organization with Analytical Solutions for Pharmaceuticals and Medical Devices.