CMC Services

Analytical Chemistry

  • Analytical Method Development/Validation/Transfer
    • Assay, Related Impurities, Chiral
    • Forced Degradation Studies
    • Residual Solvents
    • HPLC, UPLC, GC, Dissolution, LC/MS, IR, KF, etc.
  • Reference Standard Qualification
  • Method remediation or optimization
  • Development/Validation Reports
    (appropriate for “Drop In” to Regulatory Filing)

Release Testing

  • Drug Substances
  • Drug Products (all dosage forms)
  • Battery of Standard Tests
  • Compendial testing (USP, EP, & JP)
  • Excipients (Vendor Qualification Support)
  • Certificate of Analysis Generation

Stability Testing

  • Drug Substances
  • Drug Products
  • ICH (5° C, 25° C/60% RH, 30° C/65% RH, 40° C/75% RH)
  • ICH Photostability (Option 1 & 2)
  • Custom Conditions (-20° C, 50° C/75% RH, Per Customer needs)
  • Temperature Cycling Studies
  • Fully Validated Chambers – Monitored 24/7
  • Uninterrupted Power
  • Protocols
  • Submission Ready Reports

Additional Capabilities

  • Controlled Substances (DEA Schedules I – V)
  • Potent Compound Handling
  • GMP Routine Sample Testing
  • Reference Standard Subdivision and Distribution
  • Compatibility Studies
  • Cleaning Validation
  • GLP Dosing Solution Preparation
  • GLP Dosing Solution Analysis
  • GLP Stability Studies
  • CMC Support
  • CMC Consulting
  • Package Integrity
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