Method Development & Validation

Rapid, customizable, cost-effective studies

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

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

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 stressed samples are generated, they 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