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).

Olon Ricerca Bioscience’s analytical chemistry services include:


Preformulation

  • Salt and Polymorph Screening and Selection
  • Solid State Form Optimization
  • Hydrate Isolation and Characterization

Method development & validation

  • API and Drug Product Methods
  • Phase Appropriate Validation (I – IV)
  • Genotoxic Impurities

Impurities isolation & identification

  • Purification and Synthesis
  • Identification and Structure Elucidation
  • Extractables and Leachables

Materials characterization & release

  • API and Drug Product Release Testing
  • Release Standard Certification
  • Dose Formulation Analysis

Stability

  • ICH Stability Programs
  • Photostability
  • Drug Substance and Drug Product

Analytical Chemistry — Major Instrumentation

  • Atomic absorption and Graphite furnace
  • Dissolution apparatus
  • Diffusion apparatus
  • FTIR and UV–VIS spectroscopy
  • FT Raman spectroscopy
  • GC and GC–MS with headspace capabilities
  • Horiba, HIAC and microscope based particle counting
  • ICP
  • Ion Chromotography
  • KF, volumetric and coulometric
  • HPLC, UPLC and prep–HPLC
  • LC–MS/MS (3200 and 4000 Q traps)
  • NMR (400 MHz, 1H and 13C and 2–D
  • Osmometer and nephelometer
  • TGA, DSC and dynamic vapor sorption
  • XRD

Complex chemical problems have been known to bring an abrupt halt to development at some labs, but Olon Ricerca Bioscience’s specialized analytical capabilities and experience with complex chemistry usually prevents this.