Stability Testing to Support Pharmaceutical Development

As one of the major independent drug development companies in the country, Ricerca strives to maintain state-of-the-art capabilities in virtually every important service area. As an integral part of this objective we offer a wealth of experience and expertise in supporting stability investigations designed to comply with the GLP/cGMP regulatory requirements of the Food and Drug Administration (FDA) and the current International Conference on Harmonisation (ICH) guidelines.

Ricerca is your single-source solution to stability testing. To assist you in the development and registration of your drug, we can:

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

Major Equipment

Environmental chambers

• Continuously monitored and controlled
• Emergency power back-up PE Sciex API 365 and PE Sciex API III Plus
• LC-MS/MS equipped with Shimadzu binary gradients, UV systems, auto-injectors, external quaternary pumps, on-line degasser systems, and on-line ß -RAM radioactive low detectors

Liquid Chromatography

• Perkin Elmer 200/250/410 series LCs
• Varian 9010 series LCs
• Detectors include: variable wavelength, diode array, refractive index, evaporative light-scattering, fixed wavelength, and fluorescence
• Column switching capabilities
• Column heaters: range 25–75°C
• Autosampler equipped with Peltier Tray for unattended analysis of temperature labile samples from 4 to 50°C

Capillary electrophoresis

Gas Chromatography

• Hewlett Packard 5890/6890 series GCs
• Hewlett Packard 7694 Automated Headspace Analyzer
• Varian 3410, 3700, and 6000 series GCs
• Detectors include: FID, ECD, TCD, NPD, FPD (S and P), and MSD

Other services include:

• Acute, subchronic and chronic toxicology studies
• Neurotoxicity and reproductive studies
• Metabolism and pharmacokinetics investigations
• cGMP production of pharmaceutical intermediates and preclinical/clinical test materials
• GLP characterization of test and control articles (21 CFR 58.105)
• Standardized microbiological tests
• Immunoassays
• Physical characterization (particle size, surface area, pore volume, tensile/compression testing, etc.)