Quality Parameters of Honey as a Pharmaceutical Substance: Differences in Regulatory Requirements

INTRODUCTION. The Russian Federation does not have a pharmacopeial standard for honey as a pharmaceutical substance, and the current regulatory documents (GOST 19792-2017, foreign pharmacopoeias) impose different quality requirements that vary in terms of controlled parameters, test methods, and acceptance criteria. A comparative analysis of national and foreign requirements for honey quality is therefore relevant for the development of unified approaches to pharmacopeial standardization.
AIM. To perform a comparative analysis of the honey quality parameters specified in foreign pharmacopoeias and GOST 19792-2017 in order to substantiate a list of critical quality attributes that can be used in the development of a pharmacopeial monograph for honey as a pharmaceutical substance.
DISCUSSION. A literature review was conducted using the PubMed, Google Scholar, and eLIBRARY.RU databases for the period 2015–2025. A comparative analysis of the current monographs on honey in the European Pharmacopoeia (Ph. Eur.), the Korean Pharmacopoeia (KP), the Pharmacopoeia of the People’s Republic of China (ChP), the Japanese Pharmacopoeia (JP), and the United States Pharmacopeia (USP), as well as GOST 19792-2017 (GOST), was performed. Eight medicinal products (MPs) containing honey are registered in the Russian Federation; of these, honey serves as the active substance in three products and as an excipient in five. The comparative analysis of the monographs revealed substantial differences in the approaches to the standardization of honey as a pharmaceutical substance. In the Ph. Eur., identity is confirmed by the sugar profile using thin-layer chromatography (TLC); in the USP, by a qualitative reaction for proline. The content of glucose, fructose, and their ratio is determined only in the ChP and GOST. The most critical discrepancies were found for the parameters related to the thermal treatment of honey and its adulteration: the limits for 5-hydroxymethylfurfural (5-HMF) range from 25 million^–1 in GOST to 80 ppm in the Ph. Eur. and the KP, while the lists of controlled impurities in the ChP, the JP, and GOST do not coincide. Control of impurities indicative of adulteration is provided for in the ChP, the JP, and GOST, but the criteria differ: the qualitative reaction with iodine for starch and dextrin (the ChP, the KP, the JP), the reaction with tannic acid (the KP, the JP), TLC for oligosaccharides and HPLC for sucrose/maltose (the ChP), and the mass fraction of sucrose (GOST). Determination of the diastase number is provided for only in GOST. Foreign manufacturers of MPs rely on the requirements of the Ph. Eur., while domestic manufacturers rely on GOST and internal specifications, creating obstacles to harmonization. The data obtained substantiate the need for the unification of requirements for honey as a pharmaceutical substance and the revision of the current regulatory documents.
CONCLUSIONS. For the first time, a systematic comparative analysis of Russian and foreign regulatory requirements for honey quality was conducted. The analysis allowed us to identify critical discrepancies, establish a list of the most important honey quality parameters requiring harmonization, and develop a prospective list of quality parameters that can be used in the development of a pharmacopeial monograph for honey as a pharmaceutical substance.

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