The Department was founded in 1994 on the basis of the pharmacy department. It was created in 1967, when the Central Scientific and Research Laboratory of the State Academy of Medical Sciences of the Ukrainian SSR Ministry of Health was reorganized into a Pharmacy Department (heads: Ph.D. Bushkova M.M., 1967-1978; Ph.D. Kovalchuk T.V. 1978-1994) and attached to the institute. During this time, the division received 50 author's certificates and published more than 300 scientific works. In 1994, the pharmacy department was reorganized into Laboratory for Quality control of Medicines (heads: doctor of pharmaceutical sciences Sur S.V.; Ph.D. Shklyaev S.A.; doctor of pharmaceutical sciences, professor Tsurkan O.O.). From April 2015 to November 2017 - head of the Ph.D. Golembiovska O.I. From November 2017 to April 2018 acting as head of the laboratory - Ph.D. Kolyadych O.P.
The head of the laboratory (since April 2018) is Olena Kolyadych, Ph.D.
Phone: +380(44)4569825
Fax: +380(44)4569825
E-mail: derjlab@ift.org.ua
The State Laboratory for Quality control of Medicines of the State University "Institute of Pharmacology and Toxicology of NAMSU" conducts pharmaceutical analysis, development and validation of analytical methods. Experienced professionals are involved in the laboratory, a wide range of various analytical equipment is available. The methods of analysis used in the laboratory are constantly being improved in accordance with modern requirements. The work of the laboratory fully complies with international standards ISO 9001 and ISO / IES / 17025.
The laboratory is an authorized laboratory by the State Service of Ukraine for Medicinal Products and Drug Control (attestation certificate No. 573 dated 07/08/2024 is valid until 06/07/2027).
The State Laboratory for Quality control of Medicines of the State University "Institute of Pharmacology and Toxicology of NAMSU" has considerable experience (since 1999) of cooperation with foreign companies in the analysis of pharmaceutical products. In the laboratory are carried out the analysis of ready-made medicinal forms (tablets, capsules, ointments, gels, syrups, solutions for injections, etc.), active substances and control during the production of medicinal products.
The Quality Management System operates and is constantly being improved at the Laboratory.
Laboratory methods and equipment
High performance liquid chromatography
• HPLC system with UV detector, UV with photodiode matrix, refractometric index detector;
• HPLC system with a mass spectrometric detector.
Gas chromatography
• GC system with flame ionization detector, including for gas phase analysis.
Equipment for chemical and physical-chemical analysis
• Determination of disintegration, dissolution, wearability of tablets and capsules;
• Spectrophotometer (UV and Vis);
• Semi-microquantitative determination of water by K. Fisher's method and potentiometric titration;
• Determination of the melting point of substances by the capillary method;
• pH measurement;
• Automatic humidity analyzer (IR radiation);
• Refractometer;
• Determination of electrical conductivity of substances.
Other methods of pharmaceutical analysis are used: determination of density, viscosity, sulfate residue, heavy metals, loss in mass during drying, thin-layer chromatography, semi-microquantitative analysis for impurities, microscopy of plant raw materials, methods of pharmacognosy, identification of functional groups.
Areas of production activity of the laboratory
The laboratory performs the following types of analysis:
• Laboratory control at the customer's request (analysis of medicinal products, medicinal raw materials, semi-finished products and medical products using modern pharmacopoeial methods);
• Laboratory control and approbation of methods during pre-registration and re-registration quality control of medicinal products;
• Laboratory control at the direction of the State Service of Ukraine for Medicinal Products and Drug Control;
• Development and validation of analysis methods using modern pharmacopoeial methods, as well as development and testing of quality control methods for existing and prospective medicinal products, medicinal raw materials, semi-finished products, medical products;
• Establishing storage (stability) periods;
• Research of pyrogenicity, abnormal toxicity, determination of biological activity of erythropoietin.
Scientific areas of activity of the laboratory
1. Analysis of herbal medicines, medicinal plant raw materials using modern pharmacopoeial methods (HPLC, GC, UV spectrophotometry, etc.).
2. Development and approval of quality control methods for existing and prospective medicinal products of plant origin and medicinal plant raw materials.
3. Validation of methods of analysis using modern pharmacopoeial methods (HPLC, GC, UV spectrophotometry, etc.) of existing and promising medicinal products of plant origin and medicinal plant raw materials.
4. Determination of bioequivalence of medicinal products (dissolution profiles).
One doctor of pharmaceutical sciences and 8 Ph.D. were trained in the laboratory.