Comparative assessment of pharmacopoeial requirements for the quality of raw materials of the genus Linum L.

Introduction. Advancing the standardization framework for medicinal plant raw materials requires greater harmonization of pharmacopoeial specifications and more consistent approaches to quality assessment. Across national pharmacopoeias, quality requirements for raw materials derived from Linum L. species vary with respect to identification criteria, purity parameters, pharmacopoeial quality parameters of the herbal raw material (total ash, acid-insoluble ash, loss on drying, and extractable matter), and the assessment of biologically active constituents. These differences highlight the need to systematize and critically compare the requirements currently in place. Neither Linum pallescens Bunge nor Linum heterosepalum Regel is covered by the pharmacopoeias examined, underscoring the need to establish appropriate quality criteria for these species. The quality parameters and their acceptance criteria for the herbal medicinal raw materials of Linum pallescens Bunge and Linum heterosepalum Regel comply with pharmacopoeial requirements. These species are of particular interest due to the availability of a functioning domestic raw material base, the use of renewable sources of plant material, and the study of their chemical composition for the production of domestic herbal medicinal products. Aim. To conduct a comparative assessment of the pharmacopoeial quality indicators of medicinal plant materials belonging to the genus Linum L. by evaluating pharmacopoeial monographs from different countries and establishing quality specifications for the seeds of Linum pallescens Bunge and Linum heterosepalum Regel. Materials and methods. Pharmacopoeial requirements for the quality assessment of medicinal plant materials belonging to the genus Linum L. were evaluated through a comparative analysis of 13 pharmacopoeias from different countries. Results and discussion. Review of 13 pharmacopoeial monographs revealed the principal quality requirements for medicinal plant materials of the genus Linum L., together with differences in the approaches used for their identification and standardization. A comprehensive quality specification was developed for the seeds of Linum pallescens Bunge and Linum heterosepalum Regel, aimed at expanding the range of pharmacopoeial plant materials and facilitating their use by pharmaceutical manufacturers as plant material for the production of medicinal products. Conclusion. For raw materials derived from plants of the genus Linum L., a comparative assessment of pharmacopoeial quality requirements was conducted; on this basis, a quality specification was developed for Linum pallescens and Linum heterosepalum .