Compendial Testing

Release active pharmaceutical products faster and more efficiently

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 Benefits

To ensure your project’s success, we are committed to providing:

• Quality testing services
• Rapid data turnaround
• Effective communication

Catalent Services

• 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 10-business day turn-around time for release of raw materials using your 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
  • Elemental (Metal) impurities
  • Moisture
  • Particle size
  • Residual solvents
  • Enatiomeric purity
  • Impurities determinations
  • Thermal analysis

Facilities

• RTP, North Carolina, U.S.A. - Center for Development and Analytical 
  • General stats
    • Over 330+ Personnel in 200,000 sq. ft. of laboratory space
    • 9,500 sq. ft. of GMP Manufacturing for CTMs
  • Project Director Based Work Teams
    • Effective resource design including:
      • Project management
      • Project directors
      • QA
      • Scientific staff supported with administrative assistants
  • Special material handling
    • DEA-controlled substances
    • Cytoxics
    • High potency
    • Light- moisture- and oxygen-sensitive compounds
    • Cephalosporin/penicillin
    • BSL 2/3
    • Hormonals
    • Radioactive licenses
  • Laboratory facilities
    • 6 buildings in Southport Business Park
    • 200,000 sq. ft. laboratory space
    • 22,750 cu. ft. ICH stability
  • cGMP manufacturing
    • 9,500 sq. ft. 
    • Respiratory
    • Sterile (liquid/lyo)
    • Phase I/II scale
  • Operational excellence
    • Visual management of workload 
    • Metrics driven
    • Value-stream approach
• Swindon, United Kingdom
  • 158,000sq
  • EMEA, FDA, ANVISA, Turnkey MOH & AEO Approved; CT-PAT approval for Catalent US
  • Featured Technologies:
    • Zydis® fast-dissolve technology
    • Development and clinical technologies
    • Regulatory consulting services
  • Analytical Testing Services:
    • Raw material and finished product release testing
    • QP Release
    • Method Development and Validation
    • Compendial testing
    • Stability testing and storage