The scope of analyses includes:

  • chemical assay and identification
  • related substances / impurities – degradation products and other impurities (e.g. residual solvents, chiral purity)
  • identification of unknown impurities
  • vitamins analysis
  • preservatives and antioxidants analysis
  • dyes analysis
  • water content determination
  • metal analysis (as impurities)
  • macro-and microelements analysis
  • leaching and leaking tests of primary packaging materials
  • dissolution tests
  • process equipment cleaning verification and validation (with swab or rinse method)

We offer comprehensive analysis of materials (active substances and excipients) and pharmaceutical products in accordance with relevant pharmacopoeial monographs (FP, EP, BP, USP/NF) or customer specifications.

Analytical techniques

Analyses are conducted with suitable techniques corresponding with intended purpose. Depending on the needs, we use classical and instrumental techniques, such as:

  • capillary gas chromatography (GC) with flame ionization detector (FID) and thermal conductivity detector (TCD)
    • direct sample injection setup
    • headspace type injection setup
  • high-performance liquid chromatography (HPLC) and ultra high-performance LC (UHPLC) with UV/Vis (DAD) detection
  • UV/Vis spectrophotometry
  • IR spectrophotometry
  • atomic absorption spectrometry (AAS) with flame (F-AAS) and flameless atomization (graphite furnace; GF-AAS), cold vapour (CV-AAS) and hydride generation (HG-AAS) techniques, as well as atomic emission spectrometry (AES).