Harmonising Compendial Requirements for Vegetable Fatty Oils

INTRODUCTION. Vegetable fatty oils are widely used in modern pharmaceutical practice. Depending on production and purification method, they can serve as an active pharmaceutical substance and/or as an excipient. Quality and nomenclature requirements for vegetable fatty oils result from their production and purification methods.

AIM. This study aimed to harmonise national quality standards for fatty vegetable oils with the requirements of the world leading pharmacopoeias.

DISCUSSION. Aligning general pharmacopoeial monographs (GPM) with the standards of the leading world pharmacopoeias, as well as regional EAEU Pharmacopoeia is important for standardisation of biologically active compounds in order to align requirements of various pharmacopoeias. According to a comparative analysis of the leading world pharmacopoeias, the European (Eur. Pharm.) and British (BP) pharmacopoeias describe classification, production methods and purification of fatty vegetable oils. Purification allows obtaining a certain quality of oils used, among others, for production of parenteral drugs. Unlike Eur. Pharm. and BP monographs describing only production and purification methods, Japanese (JP) and United States (USP) pharmacopoeias provide identification and test methods applicable to fatty vegetable oils.

CONCLUSIONS. The analysed monographs from the leading world pharmacopoeias were used to develop a GPM draft “Vegetable Fatty Oils” harmonised with similar requirements of the leading world pharmacopoeias. The common approach classifies oils depending on production and purification method, which affects their quality and further medical use. More rigorous requirements are considered for oils intended for parenteral drugs and listed in the relevant monographs.

1. Tyutyunnikov BN. Chemistry of fats. Moscow: Kolos; 1992 (In Russ.).

2. Tereshkina OI, Rudakova IP, Petrykina EA, et al. Standardisation of fatty oils of plant origin to improve safety. Pharmacy. 2016;65(5):3–8 (In Russ.). EDN: WHNFCP

3. Seguru NV, Vandyshev BB, Rudakova IP, Samylina IA. Requirements for the pharmacopoeial article ‘Fatty oils’. Pharmacy. 2007;(8):3–5 (In Russ.). EDN: KXHIYH

4. Kadolich JV, Delikatnaya IO, Tsvetkova EA. Vegetable oils: properties and quality methods. Consumer Co-operation. 2010;(4):78–84 (In Russ.). EDN: RTXQPJ

5. Trineeva OV. Features of quality assessment and prospects of standardisation of fatty vegetable oils and oil extracts for pharmaceutical purposes (review). Drug Development and Registration. 2016;(2):114–34 (In Russ.). EDN: WYJZMH

6. Ponomarenko AA, Panova LI. Approaches to assessing the quality of fatty oils and medicinal products formulated as oily solutions. Regulatory Research and Medicine Evaluation. 2024;14(6):634–44 (In Russ.). https://doi.org/10.30895/1991-2919-2024-14-6-634-644

7. Yarutkin AV, Bagirova VL. State Pharmacopoeia of the Russian Federation edition XV: Development priorities. Regulatory Research and Medicine Evaluation. 2024;14(5):572–9 (In Russ.). https://doi.org/10.30895/1991-2919-2024-14-5-572-579

8. Polyakov LM, Knyazev RA, Kotova MV, et al. Features and quantitative characteristics of the interaction of benzo[α]pyrene with fractions of the human blood plasma lipoproteins. Siberian Scientific Medical Journal. 2021;41(2):28–32 (In Russ.). https://doi.org/10.18699/SSMJ20210204