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. Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
16. Polarimetry - specific rotation
17. Refraction - refractive index
18. Titrimetric methods (including automatic titration) using various electrodes, including phototrode
19. Dissolution (single media, dual media) using paddle, basket, oscillating cylinder, open and closed flow cell
20. Disintegration (in one medium, in two media) in solid dosage forms and suppositories
21. Hardness
22. Definition of talc, aerosil
23. Solubility
24. Melting (decomposition), solidification or boiling point
25. Density
26. Osmolality (cryoscopic and steam)
27. Transparency or color of the solution
28. Ph of a Solution
29. Acid value, saponification value, iodine value
30. Indicators of purity (chlorides, sulfates, etc.)
31. Quantitative determination: chlorides, sulfates, iron, fluorides, active chlorine, nitrates
32. Quantitative determination: mineral nitrogen containing substances
33. Determination of nitrogen in organic compounds
34. Sulphated ash and heavy metals
35. Visible mechanical inclusions (visual control method)
36. Visible mechanical inclusions - microscopic, counting-photometric method, Coulter method
37. The size of fat droplets by laser diffraction
38. Surface tension
39. Respirable fraction and determination of uniformity of the released dose
40. 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
41. Viscosity
42. Average weight and mass uniformity
43. Nominal volume
44. Geometry of tablets (diameter, height)
45. Particle size, laser diffraction method
46. Isoelectric focusing (including capillary IEF)
47. Granulometric composition of substances, laser diffraction method
48. Electrical conductivity
49. Bacterial endotoxins:
    • Method A (qualitative gel clot test)
    • Method B (quantitative gel clot test)
    • Method C (turbidimetric kinetic test)
    • Method D (chromogenic kinetic test)
50. ELISA (specific/biological activity, identity)
51. Chromogenic method for determining the activity of blood coagulation factors (including the activity of heparin-, enoxoparin-containing drugs)
52. Determination of activity by clotting method (heparin-containing drugs)
53. 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