Analytical Chemistry

Ricerca 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).

Ricerca’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 Ricerca’s specialized analytical capabilities and experience with complex chemistry usually prevents this.