Scientific and Educational Center for Control and Monitoring of the Quality of Medicines

The Scientific and Educational Center for Control and Monitoring of the Quality of Medicines of the YSU Institute of Pharmacy was established within the framework of the "Improvement of Education" loan program, the "Competitive Fund for Innovations" implemented by the Center for Education Projects of the RA MoESCS, with the funds of the "14/19-CIF" grant financed by the World Bank. The scientific leader of the project and the center is academician Ashot Saghyan, the president of RA NAS.

The official opening of the Center took place on November 16, 2021, and since 2021, based on the activity of the Center, the graduate academic program "Drug Quality Control" offered by the Chair of Pharmaceutical Chemistry and Pharmacognosy has been operating at the Institute of Pharmacy.

Accreditation areas

1. Water resources of industrial enterprises, running water. determination of mass fractions of chemical elements (Ag, Al, As, Ba, Bi, Ca, Cd, Co, Cr, Cu, Fe, K, Mg, Mn, Mo, Na, Ni, Pb, Se, Sr, Zn, V, Li) GOST R 57165-2016,

2. various tests of single-component or multi-component drugs,

3. aqueous solution of ammonia 2814 GOST 3760-79 and according to the presented SD - mass fraction of ammonia GOST 3760-79 (ST SEV 3858-82) clause 4.3,

4. chloramine 3808 GOST 1692-85 and according to the presented SD: appearance GOST 1692-85 clause 4.2, mass fraction of active chlorine GOST 1692-85 clause 4.3,

5. hydrogen peroxide 2847 00 000 0 3004 GOST 177-88 and according to the submitted SD: appearance GOST 177-88 clause 3.2, mass fraction of hydrogen peroxide GOST 177-88 clause 3.3, mass fraction of sulfuric acid GOST 177-88 clause 3.4, mass fraction of acetic acid GOST 177-88 clause 3.4.

Details are available on the website of the National Accreditation Body.

The analytical testing laboratory of the scientific and educational center is equipped with modern analytical equipment of high sensitivity and accuracy:

• Ion chromatograph, Knauer Azura, Germany
• Polarimeter H 532 Polartronic, SCHMIDT+HAENSCH, Germany
• Infrared spectrometer IR Tracer-100, Shimadzu, Japan
• Inductively coupled plasma optical emission spectroscopy, ICP-OES 5800, Agilent, USA
• High-performance liquid chromatograph with mass spectrometric detector LCMS-2020 Prominence-i, Shimadzu, Japan
• High-performance liquid chromatograph equipped with diode array detector, e2695, Waters Alliance System, USA
• High-performance liquid chromatograph with refractometric detector, Knauer Azura, Germany
• Gas chromatograph equipped with flame ionization detector and electron binding detector, GC TRACE 1310, Thermo Fisher, USA.
• Gas chromatograph with mass spectrometric detector TRACE 1610 ISQ 7610, Thermo Fisher, USA
• Microwave oven, Multiwave GO Plus, Anton Paar, Austria
• UV spectrophotometer
• Tablet dissolution tester
• Tablet friability tester

The capabilities of the center's laboratory are not limited to tests within the area of accreditation.

Services offered:

• Expertise of medicinal products and medicinal raw materials
• Validation of analytical methods, preparation of reports
• Determination of mass fractions of chemical elements in various samples
• Expertise in the field of food products, food supplements, plant materials and other matrices
• Environmental studies, in particular quantitative determination of heavy metals, persistent organic pollutants, antibiotics, hormones and other compounds in various environmental objects (soil, water)
• Conducting environmental monitoring studies
• Authentication of natural and synthetic compounds
• Quantitative and qualitative analysis of essential oils, fatty acids, sugars, alcohols, vitamins
• Evaluation of chemical and chiral purity of compounds
• Analysis of anionic and cationic composition of samples.

The center cooperates with pharmaceutical companies, food and mining industry organizations, environmental monitoring organizations, research institutes. The center also offers theoretical and practical courses for individual and group professional training in quality management and control, instrumental analysis and other topics.