Ricerca stability testing complies with all FDA requirements

As one of the major independent drug development companies in the country, Ricerca offers significant experience and expertise in supporting stability investigations designed to comply with the GLP/cGMP regulatory requirements of the Food and Drug Administration (FDA) as well as the current International Conference on Harmonisation (ICH) guidelines.

To assist in the development and registration of IND and NDA candidates, we can: 

• Develop analytical methods for drug substances and drug products
• Perform forced degradation testing
• Conduct method validation for pharmaceutical analyses
• Provide comprehensive analytical support to perform stability indicating analyses by HPLC, GC, dissolution testing and physical characterization
• Store samples for stability studies at fully monitored and validated conditions following ICH guidelines
• Provide the flexibility to meet custom storage conditions

Major Equipment

• Environmental chambers
  • Continuously monitored and controlled
  • Emergency power back-up
    
• Liquid Chromatography
  • Perkin Elmer 200series LCs
  • Detectors include: variable wavelength, diode array, refractive index, evaporative light-scattering, fixed wavelength, and fluorescence
  • Column switching capabilities
  • Column heaters: range 5-60°C
  • Autosamplers equipped with Peltier Trays for analysis of temperature labile samples from 5 to 60°C
    
• Gas Chromatography
  • Hewlett Packard 5890/6890 series GCs
  • Hewlett Packard 7694 Automated Headspace Analyzers
  • Detectors include: FID, ECD, NPD, FPD (S and P), and MSD
    
• LC-MS/MS
  • AB Sciex API 4000 (2 systems)
  • AB Sciex API 3000 (5 systems)
  • AB Sciex API 365 (2 systems)

Other services include:

• cGMP production of pharmaceutical intermediates and preclinical/clinical test materials
• GLP chemical and physical characterization of test and control articles (21 CFR 58.105)
• Standardized microbiological tests