Analytical And Stability CDMO Services
Drug product development and clinical manufacturing efforts at CoreRx are fully supported by our cGMP compliant in-house analytical laboratories. Equipped with state of the art analytical instruments, CoreRx provides analytical method support, release and stability testing services for a variety of dosage forms including oral, parenteral, ophthalmic, suppository, and topical routes of delivery.
Method Development and Validation
CoreRx provides method development, optimization, transfer, and phase appropriate qualification/validation services for a variety of dosage forms. Our services includes methods for:
Stability indicating assay and/or related substances methods, including blend uniformity and content uniformity evaluation
- HPLC & UPLC systems available for reverse phase, ion exchange or size exclusion methods.
- Detection technologies include: UV, PDA, ELSD, Fluorescence, CAD, RI and Conductivity
Single point, multi-point, and 2-stage dissolution methods
- Apparatus 1-III
- Micro dissolution baths available for R&D
Organic impurities methods using gas chromatography (GC)
Cleaning methods for support of cGMP manufacturing