In November 2020, in the Yaroslavl region in Yaroslavl, a new laboratory complex was created - the Yaroslavl branch of the Federal State Budgetary Institution "Information and Methodological Center for the Expertise, Accounting and Analysis of the Circulation of Medical Products" of the Federal Service for Surveillance in Healthcare.
The testing laboratory of the Yaroslavl branch provides the following services: testing the quality of medicines and excipients used for the preparation of medicines:
- medicines: substances, finished non-prepackaged medicines (Angro) and finished medicines (eye drops, granules, pills, injectable dosage forms, capsules, ointments, infusions and decoctions, tinctures, powders, syrups, suppositories, suspensions, tablets, extracts, emulsions, etc.);
Checking the adequacy and reproducibility of methods and techniques for quality control of medicines included in the regulatory documentation;
Information, marketing and consulting services in the field of drug circulation:
- development of methods for quality control of medicines;
- validation and verification of medicines quality control methods;
On the basis of the test laboratory, a mass spectrometry center has been launched, equipped with the most modern equipment in the field of HPLC-MS and GC-MS, which allows performing:
Medicines quality tests by ultra high-performance liquid chromatography with a high-resolution mass-selective detector and gas chromatography with a monoquadrupole ion trap in terms of foreign impurities and quantitative determination at the trace and ultra-trace levels.
Identification of the composition of unknown substances in individual form and in the composition of mixtures
Characterization of the structure of low-molecular-weight organic compounds
Identification of protein molecules
Conducting peptide mapping of proteins and products based on them
Determination and verification of the amino acid sequence of a protein
Determination of post-translational modifications of protein molecules.
Analysis of native protein isoforms.
Quality tests of samples of medicines and auxiliary components by inductively coupled plasma mass spectrometry.
The Center additionally provides consulting services in the field of development and validation of analytical methods using mass-selective detection chromatography methods.
The head of the center is Sergey Koshkin, Ph. D., author of 27 publications in scientific periodicals. Member of the All-Russian Mass Spectrometric Society.
On the basis of the Yaroslavl branch, the group of Raman spectrometry and advanced developments of the Federal State Budgetary Institution "IMTSEUAOSMP" of Roszdravnadzor is based. The main tasks of the group are:
Development of the latest methods of quality control of medicines by non-destructive testing methods using Raman spectroscopy;
Development of mathematical algorithms and software for spectrum analysis and processing;
Development of methods for testing the quality of medical gases using portable gas chromatography technology;
The list of services provided by the group includes:
Sale of the library of Raman-spectra of medicines and its own software;
Creating a library of Raman spectra for customer samples;
Conducting medicines screening by Raman spectroscopy;
Conducting tests of medical oxygen using the gas chromatography method;
Conducting tests of Medical Oxygen and Medical Nitrous Oxide according to the current Federal laws (from the 2nd quarter of 2021);
Provision of consulting services on the issue of quality control of medical gases.
Since the beginning of the formation of the group, two patents have been obtained, three methods have been certified, the state registration of the Raman spectrum database and its own software has been carried out, and more than 4 scientific articles have been published in international scientific journals. The members of the group are the authors of the draft amendments to the monographs of the State Pharmacopoeia.
In the staff of the group one professor, Ph.D. in biology, Ph.D. in pharmaceuticals, one Ph.D. in chemistry, one Ph.D. in technical sciences, chemists, pharmacists. The unit's specialists are part of the experts of the 9G (medical gases) group of the European Directorate for quality of medicines (EDQM).
Structure:
Organizational department
Analytical laboratory
Center for Mass Spectrometry
Microbiological laboratory
Pharmacological laboratory
Laboratory of immunobiological preparations
Quality service
Certificates:
Accredited for compliance with GOST ISO / IEC 17025-2009 in the Russian National Accreditation System-unique entry number in the Register of Accredited Persons: No. RA. RU. 21OB83