| I. Preclinical and Scientific Research |
| Preclinical trials |
Acute toxicity, chronic toxicity, subchronic toxicity |
| Preclinical trials |
Pharmacokinetics and metabolism |
| Preclinical trials |
Pharmacodynamics |
| Preclinical trials |
Allergenic effect, carcinogenicity, reproductive and other types of toxicity |
| Scientific research (R&D) |
Sterilizing filtration process validation |
| Scientific research (R&D) |
Validation / verification / transfer of analytical methods |
| Scientific research (R&D) |
Comparative dissolution kinetic study |
| Scientific research (R&D) |
Pharmacological research (cardiology, ophthalmology, dermatology, gerontology, oncology,
etc.)
|
| Scientific research (R&D) |
Efficacy of disinfectants. Other microbiological studies |
| II. Physicochemical Methods of Analysis |
| Description, packaging, labeling |
| Identification / Authenticity. IR spectrometry |
| Quantitative determination / Content / Mass fraction of a
substance/compound/component (protein, phosphorus, etc.), Foreign impurities / Related
impurities, optical density / Specific absorbance / Color of solution / UV absorbance,
enzymatic activity, determination of phosphorus / Phosphorus. UV/VIS spectrophotometry
|
| Identification / Authenticity, related impurities / Foreign impurities. TLC |
| Identification / Authenticity, foreign impurities / Related impurities. NMR
spectroscopy
|
| Quantitative determination. AAS |
| Identification / Authenticity / Quantitative determination, purity / Content of
isoforms / Foreign impurities / Related impurities. Capillary electrophoresis
|
| Identification / Authenticity / Quantitative determination / Content of the main
substance / Protein, foreign impurities / Related impurities / Purity / Electrophoretic
purity / Molecular weight.
|
| Gel electrophoresis (PAGE and agarose) |
| Identification / Authenticity. Chemical methods (qualitative reaction using acetic
anhydride)
|
| Authenticity / Identification / Quantitative determination / Content / Mass
fraction of a substance / compound / component, Related impurities (compounds) / Foreign
impurities / Degradation products, etc. (including chiral/stereochemical purity). HPLC (DAD,
VWD, RID, FLD detectors)
|
| Molecular weight / Molecular weight distribution / High molecular weight
impurities / Component composition / Chromatographic purity, isoform composition, Amino acid
analysis / Peptide mapping / Protein profile / Tryptic digest profile with subsequent
separation. HPLC (DAD, VWD, RID, FLD detectors)
|
| Glycan profile. HILIC method (HPLC) |
| Authenticity / Identification / Content / Quantitative determination / Mass
fraction of a substance / compound / component, Foreign impurities. UHPLC with DAD
|
| SST on the customer's column HPLC/GLC |
| Authenticity / Identification / Quantitative determination / Content / Mass
fraction of a substance / compound / component. GLC with FID
|
| Related impurities (compounds) / Foreign impurities / Degradation products. GLC
with FID
|
| Residual organic solvents. GLC with FID |
| Quantitative determination. Titrimetry (Argentometry, with an indicator and using
acetic anhydride, Potentiometric titration)
|
| Quantitative determination / Content of a substance/component. Gravimetry |
| Authenticity / Refractive index, Quantitative determination. Refractometry |
| Authenticity, Specific optical rotation / Specific rotation / Rotation angle /
Optical rotation, Quantitative determination / Mass fraction. Polarimetry
|
| Quantitative determination. Calculation method |
| Purity and limits of impurities (ammonium, chlorides, sulfates, calcium, calcium
and magnesium, zinc, nitrites and nitrates, carbon dioxide, phosphates, arsenic, heavy
metals, iron). Chemical methods
|
| Sulfated ash, Total ash, Ash insoluble in HCl, Residue on ignition / Mass fraction
of residue on ignition
|
| Quantitative determination of nitrogen / Nitrogen content / Determination of
protein / Protein content. Kjeldahl method
|
| Reducing substances, oxidizing substances, sulfites and other reducing
substances
|
| Melting point, decomposition temperature, solidification temperature |
| Dry residue / Residue on evaporation |
| Loss on drying, Absolute moisture / Moisture (of herbal raw materials and herbal
medicinal products), Thermal stability, volatile substances, moisture / Moisture mass
fraction
|
| Water. Karl Fischer method (volumetric method) |
| Acid value, Hydroxyl value (including using acetic anhydride), peroxide value,
saponification value, ester value, iodine value
|
| pH (hydrogen ion concentration) |
| Acidity or alkalinity |
| Relative density / Density (Hydrometer method, pycnometer method) |
| Ethyl alcohol / Alcohol content. Distillation method |
| Clarity of solution / Degree of turbidity of liquids, color of solution / Degree
of coloration of liquids
|
| Osmolality / Osmolarity, relative osmotic pressure, freezing point depression.
|
| Cryoscopic method |
| Electrical conductivity |
| Particulate matter (visible particles, sub-visible particles) |
| Nominal volume, extractable volume, volume of injection solutions |
| Mass (volume) of package contents, average mass and uniformity of mass / Deviation
from average mass
|
| Average mass of contents / Uniformity of mass, deliverable mass/volume of package
contents
|
| Number of doses / Average number of doses in a package, uniformity of dosage unit
mass / Uniformity of dosage units /
|
| Average mass of a single dose, delivery rate and deliverable mass/volume (for
aerosols and sprays)
|
| Talc / Aerosil / Titanium dioxide and other excipients |
| Disintegration in one medium |
| Uniformity of suppositories, ointments, metal particles (ophthalmic dosage
forms)
|
| Sedimentation stability / Sedimentation stability time, resuspension time |
| Particle size distribution / Fractional composition / Fineness / Granule size.
Sieve analysis
|
| Geometric dimensions (ophthalmic dosage forms) |
| Leak test / Container-closure integrity |
| Dissolution time / Disintegration time / Reconstitution time / Suspension time,
Syringability
|
| Solubility (in one solvent) |
| Dissolution for solid oral dosage forms |
| Dissolution by "Flow-Through Cell" method for solid forms and
suppositories
|
| Adsorption capacity |
| Uniformity of dosage units (method 1, method 2) |
| III. Microbiological and Virological Research |
| Sterility. Direct inoculation method, membrane filtration method |
| Microbiological purity according to the State Pharmacopoeia of the Russian
Federation / EAEU Pharmacopoeia (medicinal products, substances, purified water and water
for injection, perfumes and cosmetics, dietary supplements, packaging materials for medical
purposes)
|
| Bioburden (TAMC, TYMC) |
| Antimicrobial activity (direct inoculation under sterility test conditions,
membrane filtration under sterility test conditions, under microbiological purity test
conditions).
|
| Development of a method to eliminate antimicrobial activity |
| Growth promotion testing (Control of liquid culture media, Control of agar culture
media)
|
| Control of culture media for "Selective properties" |
| Control of culture media for "Diagnostic properties" |
| Antimicrobial activity of antibiotics, uniformity of dosage units (agar diffusion
method)
|
| Efficacy of antimicrobial preservation |
| Antagonistic activity, specific activity of probiotics, viable probiotic cell
count
|
| Acid-producing activity / Acidification capacity |
| Quantitative determination of heparin. Anticoagulant activity |
| Quantitative determination, authenticity, Detection of antibodies to HIV-1/HIV-2,
detection of antibodies to hepatitis B surface antigen (HBsAg), detection of antibodies to
hepatitis C virus
|
| (Enzyme-linked immunosorbent assay / ELISA) |
| Residual host cell DNA. Real-time PCR |
| Mycoplasma and Mycobacterium tuberculosis testing |
| Verification of microbial growth (visual examination during incubation of 1
control unit)
|
| Authenticity (microscopy, biochemical method) |
| Authenticity. Neutralization of antiviral activity, Specific (antiviral)
activity
|
| Specific activity. Macrophage migration inhibition test |
| Abnormal toxicity. Culture method / In vitro method |
| Microbiological environmental monitoring of production. On-site production
monitoring.
|
| Provision of plates and swabs. |
| IV. Biological Methods |
| Authenticity. Immunodiffusion in gel |
| Authenticity, specific activity, etc., by coagulometry |
| Specific activity of erythropoietin, oxytocin |
| Biological activity of insulin. Method A (rabbits), Method B (mice), prolonged
action of insulin products, bioidentity of insulins
|
| Biological activity of pantocrine |
| Biological testing of gonadotropin (1 parameter) |
| Biological activity of monoclonal antibodies (identification) |
| Pyrogenicity (in rabbits) |
| Bacterial endotoxins. LAL/TAL test (gel-clot/qualitative analysis,
chromogenic/turbidimetric/quantitative analysis)
|
| Abnormal toxicity (in mice, in rats, in guinea pigs) |
| Safety (in mice) |
| Toxicity of feed and feed additives |
| Hemagglutination assay |
| Particle size. Optical microscopy method |
| Presence of extraneous agents (for viral vaccines) |
| Anti-factor activity (one factor using the RENAM kit, using individual reagents)
|
| Other types of biological activity |
