Compendial Testing

Full-service capabilities, streamlined processes, cost-effective solutions

Our experienced employees, extensive equipment capabilities, and streamlined processes can help you in releasing active pharmaceutical ingredients, excipients, and finished pharmaceutical products faster and more efficiently. We provide full-service compendial testing per current USP/NF, PhEur/PharmEuropa, JP/JPE, FCC, ACS, AOAC, DAB, and ACS methodologies.

Catalent Services

We are committed to providing quality testing services, rapid data turnaround, and effective communication to ensure your projects success.

• Release Testing
  • Global compendial release 
    • We offer standard 10-business day turn-around time for routine compendial analysis testing from the following journals: USP/NF, PhEur, JP/JPE, AOAC, ACS, DAB, FCC, and BP.
  • Customized release testing 
    • We offer our customers 10-business day turnaround time for release of raw materials using customers specified methodologies and specifications.
  • Establishment of release specifications 
    • We offer regulatory and technical guidance in the establishment of release specifications for NCE's and new excipients.
• Method development/validation 
  • Chromatography
  • Polarimetry
  • Viscosity
  • Titrimetry
  • Metallic impurities
  • Moisture
  • Particle size
  • Residual solvents
  • Enatiomeric purity
  • Impurities determinations