Test Methods and Types

Chemical, physicochemical, immunochemical methods
  1. High performance liquid chromatography (diode array, refractive index and fluorimetric detectors, ELSD light scattering detector, charged aerosol detector, electrochemical detector)
    (Quantitative determination, authenticity, foreign matter determination, dosing uniformity)
  2. Triple quadrupole liquid chromatography-mass spectrometry
  3. Amino acid analyzer
  4. Gas chromatography (flame ionization detector, mass selective using NIST library, katharometer)
    (Quantification, Identity, Impurities, Residual Solvents, Dosage Uniformity, Dissolution)
  5. Ion chromatography using conductometric and electrochemical detectors
  6. Thin-layer chromatography by imaging and densitometry
  7. Capillary Electrophoresis (Diode Array, UV)
  8. SDS-PAGE (vertical), agarose (horizontal), acetate film electrophoresis, IEF, gel-chip electrophoresis
  9. Infrared spectrometry (IR spectrum, near infrared spectrum) by methods of frustrated total internal reflection, diffuse, gas cell
  10. Ultraviolet (UV) and visible spectrophotometry, flow cell
  11. Fluorescence spectrophotometry
  12. Near-Infrared Kinetic Nephelometry and Kinetic Turbodimetry (NIPIA)
  13. Atomic absorption spectrometry
  14. Optical emission spectrometry with various atomization methods
  15. Polarimetry - specific rotation
  16. Refraction - refractive index
  17. Titrimetric methods (including automatic titration) using various electrodes, including phototrode
  18. Dissolution (single media, dual media) using paddle, basket, oscillating cylinder, open and closed flow cell
  19. Disintegration (in one medium, in two media) in solid dosage forms and suppositories
  20. Hardness
  21. Definition of talc, aerosil
  22. Solubility
  23. Melting (decomposition), solidification or boiling point
  24. Density
  25. Osmolality (cryoscopic and steam)
  26. Transparency or color of the solution
  27. Ph of a Solution
  28. Acid value, saponification value, iodine value
  29. Indicators of purity (chlorides, sulfates, etc.)
  30. Quantitative determination: chlorides, sulfates, iron, fluorides, active chlorine, nitrates
  31. Quantitative determination: mineral nitrogen containing substances
  32. Determination of nitrogen in organic compounds
  33. Sulphated ash and heavy metals
  34. Visible mechanical inclusions (visual control method)
  35. Visible mechanical inclusions - microscopic, counting-photometric method, Coulter method
  36. The size of fat droplets by laser diffraction
  37. Surface tension
  38. Respirable fraction and determination of uniformity of the released dose
  39. Loss on drying or water determined by the method of K. Fischer
    • volumetric method
    • coulometric method with additional use of an evaporative oven for solid samples
  40. Viscosity
  41. Average weight and mass uniformity
  42. Nominal volume
  43. Geometry of tablets (diameter, height)
  44. Particle size, laser diffraction method
  45. Isoelectric focusing (including capillary IEF)
  46. Granulometric composition of substances, laser diffraction method
  47. Electrical conductivity
  48. Bacterial endotoxins:
    • Method A (qualitative gel clot test)
    • Method B (quantitative gel clot test)
    • Method C (turbidimetric kinetic test)
    • Method D (chromogenic kinetic test)
  49. ELISA (specific/biological activity, identity)
  50. Chromogenic method for determining the activity of blood coagulation factors (including the activity of heparin-, enoxoparin-containing drugs)
  51. Determination of activity by clotting method (heparin-containing drugs)
  52. Determination of hemolytically active substances
Biological methods
  1. Pyrogenicity
  2. Abnormal toxicity (basic test, test for vaccines and sera)
  3. Harmlessness
  4. Test for depressant (histamine-like) substances
  5. Histamine test
  6. Biological testing of insulins: bioidentity, biological activity, long-acting
  7. Biological evaluation of cardiac glycosides in frogs
  8. Biological testing of ganadotropins
  9. Anticoagulant activity
  10. Determination of the activity of enzyme preparations
  11. Specific activity of erythropoietin preparations (microscopic method, flow cytometer)
  12. Determination of specific/biological activity by methods using mammalian cell cultures
  13. Real-time PCR testing
Bacteriologic methods
  1. Microbiological purity
  2. Sterility (direct inoculation method)
  3. Sterility (membrane filtration method)
  4. Control of nutrient media in terms of growth, selective and diagnostic properties
  5. Definition of antimicrobial activity
  6. Determination of the antimicrobial activity of antibiotics by agar diffusion
  7. Quality control of bifido- and lacto-containing bacteria
  8. Specific activity and identity of bacteriophages (Appelmann method)
  9. Microbiological monitoring