Analytical and Stability
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…
