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

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.

fish oil, Pharmacopoeia of the USA, British Pharmacopoeia, quality standards, standardization of medicines