Method Development & Validation

Expertly meeting the specificity demands of analytical assays

Stressed samples of drug substance and drug product are critical to demonstrate the specificity of an analytical assay. Samples are essential to method development and validation.

Catalent Benefits

Our focused studies provide a range of benefits that can enhance your final outcome:

• Rapid and inexpensive
• Custom designed for your drug substance based on structure and functional group sensitivity
• Produce mainly degradants likely to form during formal studies
• Produce samples quickly and inexpensively for support of MD/MV activities

Catalent Services

• Full degradation studies can include:
  • Photodegradation 
    • Option I or II
  • Chemical 
    • Acid, base, and neutral conditions
  • Oxidative
    • Peroxide based, oxygen mediated, radical initiate - with or without quenching
  • Heat and humidity stressing of samples 
  • Once generated, stressed samples will be evaluated by our team to provide you with essential information such as:
    • Degradation profile
    • Qualitative or quantitative description of degradation pathways
    • Kinetics
    • Structural elucidation of degradants using techniques such as diode array, mass spectrometry, and NMR

How It Works

Ranitidine shows little degradation under control, neutral, or heat with ambient humidity conditions but is susceptible to degradation by acid, base, elevated humidity, and peroxide. One of the oxidation products, ranitidine-related compound C, was identified and quantified.

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