The Laboratory of Pharmacopoeial Analysis of the State Enterprise «Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines» uses unique biological methods of medicines quality control

The Pharmacopoeial Analysis Laboratory of the State Enterprise «Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines» located in Kharkiv is one of the authorized laboratories of the State Service of Ukraine on Medicines and Drugs Control, which continues to perform its work in the sphere of medicines quality control using unique biological control methods and despite all the risks connected with the military aggression of the Russian Federation against Ukraine.

The Group of Biological Methods of Analysis of the Pharmacopoeial Analysis Laboratory at the State Enterprise «Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines» conducts testing of medicines and substances according to the standards of the State Pharmacopoeia of Ukraine:

«Bacterial endotoxins» by compendial methods: gel-clot methods (methods A and B), turbidimetric kinetic method (method C), chromogenic kinetic and chromogenic end-point methods (methods D and E).

Identification and Quantification of activity of low molecular weight and standard unfractionated heparins using modern highly specific methods (chromogenic kinetic method and end-point method) for the evaluation of their anticoagulant antifactor Xa-and antifactor IIa-activity in accordance with the general article of the State Pharmacopoeia of Ukraine, 2.7.5. «Quantification of Heparin», as well as quantification of activity and identification of heparin by coagulometric method.

Pyrogenic medicines contamination, the regulatory documentation of which contains a reference to the general article of the State Pharmacopoeia of Ukraine 6.8. «Pyrogens». The pyrogen test in rabbits is also used to determine pyrogenic contamination at the stage of new alternative methods of pyrogenicity control development.

The Group of Biological Methods of Analysis of the Pharmacopoeial Analysis Laboratory at the State Enterprise «Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines» is the first and only one in Ukraine that conducts tests for depressant substances, which allows to detect dangerous impurities of histamine-like substances in natural and half-synthetic drugs and to prevent a clinically significant decrease in systemic blood pressure in humans.

Also, The Group of Biological Methods of Analysis of the Pharmacopoeial Analysis Laboratory at the State Enterprise «Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines» is the only one in Ukraine that conducts quality control of plant raw materials and medicinal plant products according to the general article 2.7.N1. «Quantitative determination of cardiac glycosides by in vivo method» on frogs and evaluation of the reactogenic properties of the infusion solution of Rheopoliglucin and dextran substance by the «Antigenicity» indicator on marmosets to exclude the development of a severe anaphylactoid reaction, which can lead to death, when the drug is used in the clinic.

In addition to the analyzes performed by the Pharmacopoeial Analysis Laboratory of the State Enterprise «Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines» for the pharmaceutical market of Ukraine, it technically supports the development of the State Pharmacopoeia of Ukraine, which is a regulatory document containing general requirements for medicines, monographs and methods for controlling active substances, medicines, reagents, etc.

Ukraine was the first country in the former Soviet Union, which developed a national pharmacopoeia. The first edition of the State Pharmacopoeia of Ukraine was implemented on October 1, 2001.