Olon Ricerca Bioscience

Analytical chemistry

Analytical chemistry

Olon Ricerca Bioscience provides you with a comprehensive range of on-site analytical chemistry services to fully support the drug development process, from preclinical to post-marketing phases. We have decades of experience conducting studies in compliance with the US FDA– GLP/cGMP regulatory requirements and the International Conference on Harmonisation (ICH).

Analytical-Chemistry-Quality-Control

Comprehensive research, development and manufacturing support of drug substance, drug product and specialty materials

Primary Service Offerings

• API drug substance & drug product method development & validation
• Impurity identification & structural elucidation
• Materials characterization
• Manufacturing support – QC & IPC
• Dose formulation analysis
• Storage stability programs
• Pre-formulation – Salt, polymorph & co-crystal screening
• Extractable and leachable programs

Primary Instrumentation/Equipment

• HPLC, UHPLC and prep-HPLC
• Ion Chromatography
• GC-MS and GC with headspace capabilities
• LC-MS/MS (Q trap)
• NMR (including 2-D)
• FTIR and Raman spectroscopy
• UV-VIS spectroscopy
• Light scattering and microscope-based particle characterization
• ICP-OES/ICP-MS
• KF, volumetric and coulometric
• TGA, DSC, and dynamic vapor sorption
• XRPD
• Osmometer, Viscosity, Polarimetry
• Storage Stability Chambers/Facility