Comparison of Pharmacopoeial Requirements for the Quality of Fish Oil in USA and the Great Britain

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DOI: https://doi.org/10.29296/25419218-2021-01-04
Issue: 
1
Year: 
2021

V.V. Lopatin, A.N. Fetisova I.M. Sechenov First Moscow State Medical University (Sechenov University), 8, Trubetskaya St., Build. 2, Moscow, 119991, Russia

Introduction. Currently, the number of highly effective drugs is growing on the global pharmaceutical market, and the requirements for methods for assessing the quality of medicinal substances are becoming more stringent. At the same time, there is a clear lag in domestic developments of new methods of analysis in comparison with foreign countries. Aim of the study. The aim of the study is to compare the pharmacopoeial requirements for assessing the quality of a fish oil substance in the USA and Great Britain, as well as to determine potential indicators of the quality of a fish oil substance and methods for their assessment that can be used by domestic manufacturers. Methods. Сomparative analysis of pharmacopoeial sources and regulatory documents that are freely available. Results. The analysis of pharmacopoeial requirements for assessing the quality of the substance of fish oil in the United States and the UK was provided. As a result of a comparison of requirements and standardization methods, it has been established that the regulatory documentation governing the assessment of the quality of the fish oil substance in the United States of America practically coincides with the requirements in the British Pharmacopoeia. This indicates close cooperation between Western countries in the development of new methods for assessing the quality of the fish oil substance and dosage forms based on it. Conclusion. Foreign experience in the use of modern methods of analysis of fish oil can be used to improve the relevant articles of the domestic pharmacopoeia, as well as in various regulatory documents.
Keywords: 
fish oil
Pharmacopoeia of the USA
British Pharmacopoeia
quality standards
standardization of medicines
References: 
  1. British Pharmacopoeia. 2012.
  2. Pharmacopoeias of USA. 2009.
  3. U.S. Food and Drug Administration. Electron resourse. Access regimen: https://www.fda.gov/. (Date of the address: 18.12.2018).
  4. Regulation No 853/2004 of the European Parliament and of the council of 29 April 2004. European Parliament and the council. Committee on the Food Chain and Animal Health. Strasbourg, 2004.
  5. M.P. Castro-Gomez, F. Holgado. Comprehensive Study of the Lipid Classes of Krill Oil by Fractination and Indentification of Triacylglycerols, Diacylglycerols and Phospholipid Molecular Species by Using UPLC/QToF-MS. Food Analytical Methods. 2015; 8 (10): 2568–80.
  6. Aurelia Bratu, Anamaria Hanganu, Nicoleta Chira, Cristina Todasca. Quantitative determination of fatty acids from fish oils using GC-MS method and 1H-NMR spectroscopy. UPB Scientific Bulletin, Series B. 2013; 75 (2): 23–32.
  7. Fetisova A.N. Perspektivy ispol'zovanija sverhkriticheskoj fljuidnoj hromatografii v otsenke kachestva ryb'ego zhira i lekarstvennyh preparatov na ego osnove (V.V. Lopatin, A.N. Fetisova). Sbornik materialov XXV Rossijskogo natsional'nogo kongressa «Chelovek i lekarstvo» (09–12 aprelja 2018 g.). Tezisy dokladov. M.: Vidoks, 2018; 115. [Fetisova A.N. Prospects for the use of supercritical fluid chromatography in assessing the quality of fish oil and medicines based on it (V.V. Lopatin, A.N. Fetisova). Sbornik materialov XXV Rossijskogo nacional'nogo kongressa «CHelovek i lekarstvo» (09–12 aprelya 2018 g.). Tezisy dokladov. M.: Vidoks, 2018; 115 (in Russian)].
  8. Liton Roy, Chad S. Harrell, Alan S. Ryan. Development and Validation of a Single HPLC Method for Analysis of Purines in Fish Oil Supplements. Food and Nutrition Sciences. 2013; 4 (12): 1255–9.
  9. State Pharmacopoeia XIV edition, vol. 4. Moscow: NC ESMP, 2018