Analytical Research Section

Head of Section

Marta Zezula, PhD

tel. +48 22 568 26 70

Team of Analytical Research carries out studies on the full analytical characterization of chemical and pharmaceutical substances as well as analytical expertise for various pharmaceutical forms (tablets, capsules, solutions, eye drops in the form of solutions and suspensions, emulsions and ointments). On the basis of the conducted research, documentation is prepared that meets the requirements of committees creating drug quality criteria, including the International Conference on Harmonization of Drug Registration Requirements (ICH) and European and American Registration Offices.

The Research Analytics team cooperates with scientific and industrial institutions, carrying out analytical work as part of scientific projects. The results of research work are presented in national and international journals, as well as at scientific conferences.

Scope of activity

Expertise, development and validation of methods in the field of:

  • determination of the chemical and enantiomeric purity and assay of chemical and pharmaceutical substances (HPLC, UHPLC with UV / VIS detection, PDA, Corona CAD, MS)
  • determination of complete impurity profiles including genotoxic impurities
  • studies on the compatibility of the active substance with excipients at the stage of development research
  • residual solvents analysis (GC-FID, GC-HS, GC-MS),
  • determination of assay by potentiometric titrations
  • determination of trace elements (ICP-MS)
  • determination of water content using the Karl Fischer volumetric and coulometric titrations,
  • elucidation of chemical structure (NMR, IR, Raman spectroscopy, X-ray single crystal and powder diffraction)
  • analysis of phase transformations in a solid state, including the polymorphic transformation (quantitative and qualitative phase analyses, calculation of crystalline fraction)
  • determination of particle size and shape distribution profiles
  • stability studies under accelerated and long-term conditions.

Polymorphism studies

  • X-ray powder diffraction (XRPD)
  • X-ray monocrystalline diffraction
  • differential scanning calorimetry (DSC)
  • infrared spectroscopy (FTIR / ATR)
  • Raman spectroscopy

Preformulation studies

  • laser diffraction
  • automatic microscopic analysis
  • test of the solubility of active substances according to PH. Eu.

Analysis in the GMP system

  • X-ray powder diffraction (XRPD)
  • gas chromatography with mass spectrometry detection (GC-MS)
  • nuclear magnetic resonance (NMR 500 MHz)
  • elemental analysis (ICP-MS)

Drug Form Analysis

  • preformulation studies: analysis of solubility and release profile
  • physicochemical and pharmaceutical research for various pharmaceutical forms
  • analysis of dietary supplements (identity, content, heavy metals)
  • analysis of natural (identity, content and release) as well as veterinary (identity, content, release and chemical purity) products.