Analytical chemistry plays a key role in pharmaceutical and medical device R&D. Appropriate characterization of the formulation or device is crucial in developing and commercializing ophthalmic products. Oculos has decades of experience in providing analytical chemistry support for pharmaceutical and medical device customers. A partial list of key services and equipment are as follows:
Services:
- Analytical method development/validation
- Forced degradation studies
- Impurity identification/structure elucidation and quantification
- Chemical characterization of test article (in accordance with ISO 13485-18)
- Extractable/Leachable protocol development/execution/reporting
- Accelerated and real-time stability studies (in accordance with ICH)
- Quality control/product release testing
Equipment:
- LC/MS (ThermoFisher Q-Exactive)
- GC/MS
- GC/GC with headspace detection
- HPLC (Shimadzu/Waters)
- Ion chromatography
- UV/Vis
- ICH stability chambers (Bahnson)
- Waters Empower 3.0 chromatography data software
- TOC/Conductivity
- Osmometer
