Pharmacopeial Approaches to Standardization of Excipients Exemplified by Propylene Glycol and Its Derivatives

INTRODUCTION. Amendments to Federal Law No. 61-FZ On Circulation of Medicines provide for additional data on excipients in general pharmacopeial monographs and pharmacopeial monographs; this necessitates the improvement of standardization requirements for excipients at a legislative level.

AIM. This study aimed to determine the main growth vectors of pharmacopeial approaches to excipient standardization, as exemplified by propylene glycol and its derivatives.

DISCUSSION. The study considered the concept of excipients and their standardization requirements at the national, regional, and international levels. It was established that the term “substances for pharmaceutical use” most correctly describes pharmacopeial approaches to excipient standardization. It was revealed that the number of excipient names for medicinal products available on the Russian pharmaceutical market remains a relevant issue. Approaches from the State Pharmacopoeia of the Russian Federation, the Pharmacopoeia of the Eurasian Economic Union, and foreign pharmacopeias (US, Europe, China) were compared regarding standardization of general quality requirements for excipients and specific requirements for propylene glycol and its derivatives. It was established that pharmacopeial requirements for excipients are based on an integrated approach that defines general quality parameters for the substances and assesses additional parameters that depend on the performance. A list of performance parameters was compared for various national pharmacopeias; noteworthy, the designations on the list were not always standardized.

CONCLUSIONS. The pharmacopeial approach to excipient standardization is a critical tool for ensuring quality, efficiency, and safety of medicinal products. Based on the analysis of quality control data for propylene glycol and its derivatives, key pharmacopeial methods of excipient standardization include: developing and updating monographs for excipients; improving the requirements for universal quality parameters of excipients as per monograph Substances for Pharmaceutical Use and establishing performance requirements; expanding the range of excipients included in the State Pharmacopoeia of the Russian Federation; and increasing the number of pharmacopeial standards for certain excipients upon analysis and harmonization of national, regional, and international requirements.

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