State Pharmacopoeia of the Russian Federation

In Russia, the first Pharmacopoeia was published in 1765 in Latin, it was a non-governmental publication intended for the needs of military hospitals ^[1] .

The first state civil pharmacopeia of Russia ( Pharmacopoea Rossica , in Latin) was published in 1778 ^[2] . The second state pharmacopoeia was published in 1798; in 1802, it was translated into Russian, becoming the first pharmacopeia in the national language in history ^[1] .

The first official publication of the Pharmacopoeia in Russian was published in 1866 ^[3] .

In the second half of the 19th century, professor and academician Yu. K. Trapp , compiler of the third edition of the State Pharmacopoeia (1880), as well as the Military Pharmacopoeia (1864), the Marine Pharmacopoeia (1869), and the Court Court made a great contribution to the development of Russian pharmacopeias . Pharmacopoeia ”(1871) and“ Pocket Pharmacopoeia ”(1881) ^[4] .

The chief editor of the seventh edition of the State Pharmacopoeia (1925) was Academician of the USSR Academy of Sciences A. E. Chichibabin .

List of official pharmacopoeia publications in Russian ^[3] :

• The first edition of the Russian Pharmacopoeia was published in 1866.
• Wopoe edition of the Russian Pharmacopoeia - in 1871
• The third edition of the Russian Pharmacopoeia - in 1880,
• The fourth edition of the Russian Pharmacopoeia - in 1891,
• The fifth edition of the Russian Pharmacopoeia - in 1902,
• The sixth edition of the Russian Pharmacopoeia - in 1910,
• The seventh edition of the Pharmacopoeia of the USSR - in 1925,
• The eighth edition of the Pharmacopoeia of the USSR - in 1946,
• The ninth edition of the Pharmacopoeia of the USSR - in 1961,
• The tenth edition of the Pharmacopoeia of the USSR - in 1968,
• Eleventh edition of the State Fund of the XI USSR
  • - first release - in 1987
  • - second edition - in 1989 (incomplete publication)

The compilation, addition and reprinting of the Pharmacopoeia was carried out by the Pharmacopoeia Committee. In GF XI, pharmacopoeial articles were introduced for each drug and general methods for their control.

• Twelfth edition of the RF GF:
  • - part one - in 2007
  • - part two - has not been officially published.
• The thirteenth edition of the RF GF was published in 2015 ^{[5] [6]}
• The fourteenth edition of the RF State Fund was published on November 7, 2018 ^[7]

In the period between publications of the RF GF, the quality of new substances and preparations was regulated with the help of the pharmacopoeial article of the enterprise (FSP), pharmacopoeial article (FS) and the general pharmacopoeial article (OFS).

The preparation of PF XII was influenced by the participation of the Russian Federation in the work of the Commission of the European Pharmacopoeia .

GF RF XII consists of five parts. Financing was carried out at the expense of funds from the sale.

• The first part of the RF Civil Fund of the XII edition was published in 2008 with a circulation of 100 thousand copies, and was put into effect in 2009 ^[8] . During the release, it was emphasized ^[9] that, pursuant to the guidelines ^{[10] [11],} each pharmacy and wholesaler is required to have the RF Civil Fund XII as a collection of basic standards and regulations that regulate the quality of medicines used in pharmacopoeial analysis and production. The first part of the RF Civil Fund XII contains 45 OFS and 77 FS on pharmaceutical substances, including those included in the List of Essential and Essential Medicines . The articles describe the characteristics and / or properties of various dosage forms, methods for studying the quality characteristics of drugs, FS determine the quality requirements of drugs, pharmaceutical substances and excipients.

The editorial board included representatives of the Ministry of Health and Social Development, Roszdravnadzor ^[12] , Roszdrav, FFOMS and leading Russian scientists ^[13] .

At the end of 2015, an electronic version of the XIII edition of the State Pharmacopoeia of the Russian Federation was published ^{[5] [14]} .

Pharmacopoeia article and Pharmacopoeia article of the enterprise, among other things, have the following sections:

• The name of the substance in Russian and Latin.
• International Nonproprietary Name (INN).
• Chemical name in accordance with IUPAC .
• Synonyms, empirical and structural formulas , relative molecular weight , content of the main active substance .
• The description contains indicators of the appearance of the drug substance.
• Authentication criteria, including UV and IR absorption spectra and physical constants of a substance.
• Solubility, including in water and ethanol .
• In addition, physical, physico-chemical and chemical indicators, the permissible content of impurities and mechanical impurities, conditions of transportation, storage, shelf life and pharmacological action of the substance are given.

To the above contains:

• tests of characteristics and parameters,
• permissible deviations of mass, volume, particle size,
• uniformity of dosing.

• Pharmacopoeia // Ulyanovsk - Frankfort. - M .: Soviet Encyclopedia, 1977. - ( Great Soviet Encyclopedia : [30 vol.] / Ch. Ed. A. M. Prokhorov ; 1969-1978, vol. 27).
• Belikov V.G. Pharmaceutical chemistry. - M., 2007.
• State Pharmacopoeia of the Russian Federation XII.
• State Pharmacopoeia of the Russian Federation XIII.
• OST 91500.05.001.00 Quality standard of medicines.
• State Pharmacopoeia of the Russian Federation XIV. ( http://femb.ru/femb/pharmacopea.php )