Test Methods and Types

Chemical, physicochemical, immunochemical methods
  1. High performance liquid chromatography (diode array, refractometric and fluorimetric detectors, light-scattering detector ELSD, charged aerosol detector)
    (Quantitative determination, identification test, impurities detection, dose uniformity)
  2. Liquid chromato-mass-spectrometry with triple quadrupole.
  3. Gas chromatography (FID, mass selective triple quadrupole)
    (Quantitative determination, identification test, impurity detection, residual solvent detection, dose uniformity)
  4. Ion chromatography
  5. Thin-layer chromatography
  6. Capillary electrophoresis (diode array, conductometric electrophoresis)
  7. Electrophoresis in polyacrylamide gel
  8. IR spectroscopy (infrared spectrum, near-infrared spectrum)
  9. Ultraviolet region spectroscopy (UV spectrum)
  10. Rate nephelometry and kinetic turbidimetry (NIPIA)
  11. Atomic absorption spectrometry
  12. Optical emission spectrometry
  13. Polarimetry - specific optical rotation
  14. Refractometry - refraction index
  15. Titration methods (including automatic titration)
  16. Dissolution (in one medium, in two mediums)
  17. Disintegration (in one medium, in two mediums)
  18. Hardness
  19. Talc, aerosil detection
  20. Solubility
  21. Melting  (desintegration), solidification or boiling temperature
  22. Density
  23. Osmolality
  24. Solution clarity or colourity
  25. рН
  26. Acid value, saponification value, iodine absorption value
  27. Purity index (chlorides, sulfates, etc.)
  28. Quantitative determination of chlorides, sulfates, iron, fluorides, active chlorine, nitrates
  29. Quantitative determination of mineral nitrogen substances
  30. Nitrogen detection in organic compounds
  31. Sulfate ash and heavy metals
  32. Visible mechanical impurities (visual control method)
  33. Subvisible mechanical impurities - microscopic, photometric counting method and Coulter Principle
  34. Fat droplet size
  35. Surface-tension
  36. Respirable fraction and delivered dose uniformity detection
  37. Weight loss on drying or water determined with Fisher’s method
    • volumetric method
    • coulometric method
  38. Viscosity
  39. Average weight and uniformity of filled weight
  40. Nominal volume
  41. Pill geometry (diameter, height)
  42. Particle size, laser diffraction method
  43. Isoelectrofocusing (including capillary IEF)
Biological methods
  1. Pyrogenicity
  2. Toxicity
  3. Content of histamine-like agents
  4. Depressor agents
  5. Bioactivity
  6. Anticoagulant potency
  7. Enzymatic agent activity test
  8. Specific activity
  9. Flow cytometry
Bacteriologic methods
  1. Microbiological purity
  2. Sterility (direct inoculation method)
  3. Sterility (membrane filtration method)
  4. Bacterial endotoxins (qualitative and quantitative analysis)
  5. Nutritional medium control in terms of growth properties and selectivity
  6. Antimicrobal activity determination
  7. Antimicrobal activity of antibiotics determination by diffusion in agar
  8. Bacteriophage specific activity
  9. Enzyme immunodetection