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