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  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica

Pharmaceutical analyses

 

Pharmaceutical analyses

The Department of Pharmaceutical Analyses (PAD/QC) provides a wide range of analytical services in the field of pharmaceutical analysis including quality control. The work is conducted under GMP (Good Manufacturing Practice) rules and ICH (International Conference on Harmonization) recommendations are followed. The following profile shows the main tasks of PAD/QC:

Provided analytical services:

  • Method validation and method transfer
  • Stability studies on drug substance and/or dosage form
  • Analyses of highly potent drugs
  • Quality control, release testing of pharmaceutical products
  • Analytical support of formulation development
  • Analytical support of manufacturing process validation
  • Analytical reports including Certificates of Analysis
  • Application of ICH recommendations

 

Long-term experience with the following analytical techniques:

  • UPLC, HPLC, TLC, GC, GC-HS
  • Dissolution
  • Hardness and friability
  • Disintegration
  • Particle size distribution by laser diffraction and image analysis
  • Particulate matter
  • Infrared and UV spectroscopy
  • Optical rotation
  • Titration assay
  • Classical pharmacopoeial tests (melting point, pH, filled content, clarity and color tests, sulphated ash, loss on drying, water content, heavy metals, appearance)