About company

О компании

Laboratory of physical and chemical methods of analysis

Laboratory of physical and chemical methods of analysis

The laboratory is equipped with modern analytical equipment in accordance with the requirements of GLP and carries out the widest range of analytical studies in accordance with the area of accreditation of the testing center.

Main areas of accreditation:
  • quality control of medicines for compliance with normative documents;
  • development and validation of analytical methods;
  • standardization of normative documents for medicines;
  • study of drug stability;
  • study of dissolution kinetics;
  • scientific and practical research;
  • pharmacokinetic studies in the framework of bioequivalence;
  • carrying out the transfer of methods.

Department of Pharmacological Research

Department of Pharmacological Research
The main activities in the field of quality control:
  • Pyrogenicity;
  • Abnormal toxicity and harmlessness
  • Testing of viral vaccines for the presence of foreign agents
  • Toxicological testing of medical devices according to GOST ISO 10993, GOST R 52770
  • Toxicological testing of feed, compound feed and feed raw materials according to GOST 31674
  • Toxicological tests of perfumery and cosmetic products according to GOST 33506
  • Studies of the specific biological activity of erythropoietin in vivo by flow cytometry, as well as microscopically
  • Studies of the specific biological activity of gonadotropins in vivo
  • Studies of the anticoagulant activity of blood coagulation factor preparations in vitro
  • Biological testing of insulin in vivo (biological activity, prolonged action, bioidentity)
  • Anticoagulant activity of preparations and substances of heparin and low molecular weight heparin in vitro
  • Bacterial endotoxins (qualitative and quantitative gel thrombus test)
  • optical microscopy
  • Linked immunosorbent assay
  • Immunogenic activity of vaccines
  • Specificity/specific activity of a number of allergens
  • Other tests of biological drugs in accordance with the requirements of the Global Fund, BP, USP, EP

Preclinical testing of products on laboratory animals:
  • Acute and chronic toxicity
  • Pharmacokinetics, toxicokinetics
  • Pharmacodynamics and specific activity
  • Mutagenicity with predicted carcinogenicity
  • Embryotoxicity with teratogenicity
  • Allergenicity, immunotoxicity
  • Local irritant action.

Department of Microbiological and Virological Research

Department of Microbiological and Virological Research

The laboratory has a license of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare No. dated April 30, 2009 for diagnostic testing of material contaminated or suspected of being contaminated with microorganisms and sanitary-indicative microorganisms of groups III-IV pathogenicity. Storage of microorganisms of III-IV groups of pathogenicity. This license was reissued on the basis of the decision of the licensing authority - Order No. 95 dated 09/04/2019.

The total area of the premises of the department is about 400 sq.m. The premises of the department and their engineering equipment comply with the state sanitary and epidemiological rules and regulations for testing laboratories that work with PBA of III-IV pathogenicity groups.

The department has a technical base, including the necessary test equipment and measuring instruments, standard nutrient media, a working collection of museum cultures (bacteria and fungi of pathogenicity groups III-IV, viruses of pathogenicity group IV).

On the basis of the department, research work is carried out to develop and validate analysis methods, conduct preclinical trials of both generic and innovative medicines, microbiological quality control of finished medicines, substances, etc. according to the approved normative documents.