Analytical and Stability

CoreRx® > Solutions > 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…
Analytical Control & Stability Testing
Analytical Capabilities
Method Development & Validation

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
Drug Product Release & ICH Stability Services
Drug Product Release & ICH Stability Services

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!

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