Analytical Services, Methods Development & Validation and Stability
Drug product development, clinical manufacturing and commercial manufacturing efforts at CoreRx are fully supported by our GMP compliant in-house analytical laboratories, governed by robust Quality systems. Equipped with state-of-the-art analytical instruments, with activities executed by a talented and experienced team, 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.
Analytical Capabilities
Full PD and QC Testing Support
- Stability testing: 2-8C, 25C/60%RH, 30C/65%RH, 40C/75%RH, custom conditions available/freeze thaw
- ID – FTIR, UV, XRD
- ID/Assay/Related Substances and Chiral Purity
- HPLC: UV, PDA, ELSD, fluorescence, CAD, RI, conductivity (Agilent, Waters and Shimadzu)
- UPLC: CAD with PDA, ELSD with PDA, ACQUITY QDa mass detector with PDA (Waters and Shimadzu)
- Discriminating dissolution – H/UPLC and SoTax/UV; biorelevant media, Pion
- Moisture content – LOD and Karl Fischer
- GC: Multiple systems including head space for residual solvents, detectors attached to flame ionization detector (FID)
- XRD, DSC/TGA, DVS, SEM, Light microscopes, Malvern 3000 Mastersizers, Raman, ATM sonic sifter, others…



Method Development & Validation
CoreRx provides method development, optimization, transfer, and phase appropriate qualification/validation services for a variety of dosage forms.
- HPLC & UPLC Assay & Related Substance Methods
- Single Point, Multi-Point and Two-stage Dissolution Methods
- Preliminary Impurity Characterization Using the Single Quad Mass Spec
- Mass Determination for Impurities
- Franz Cell Permeability Assay Methods
- Blend and Content Uniformity Methods
- GC Assay Methods for Organic Impurities
- Cleaning Methods for Support of GMP Manufacturing
Drug Product Release & ICH Stability Services
CoreRx offers comprehensive drug product release & stability services as either stand-alone projects, or in support of full development and manufacturing programs conducted at CoreRx.
Our QC Services Include:
- Analytical Method Qualification: Verification, Transfer, and Validation
- Release Testing & Certificate of Analysis
- Stability Protocol Generation
- Stability Storage
- Stability Testing
- Stability Summary Report Generation
- Stability Time Points and Conditions
- iStability LIMS for Stability Trending
- Ad Hoc Report Generation


End-To-End Solutions
CoreRx provides End-To-End solutions—no need to risk your drug program by moving between disconnected providers. From pre-formulation to commercial GMP manufacturing and packaging, CoreRx is a complete solutions provider. Contact us to learn more!