SCIENTIFIC AND ANALYTICAL CHALLENGES IN QUALITY CONTROL, AUTHENTICATION, AND STANDARDIZATION OF MEDICINAL PLANT RAW MATERIALS UNDER CONDITIONS OF MULTICOMPONENT CHEMICAL COMPOSITION VARIABILITY
Keywords:
Their qualitative and quantitative composition varies depending on the botanical species, plant organ, ecological and geographical conditions, growth stage, harvesting time, and processing and storage conditions. Such natural variability poses significant challenges to the authentication of raw materials, the assurance of consistent quality, and the development of scientifically justified standardization criteria.Abstract
Medicinal plant raw materials represent complex multicomponent systems composed of biologically active and auxiliary compounds belonging to various chemical classes.
References
World Health Organization. Quality Control Methods for Herbal Materials. Geneva: WHO; 2011. ISBN: 9789241500739.
European Medicines Agency. Guideline on Specifications: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products/Traditional Herbal Medicinal Products. EMA/HMPC/CHMP/CVMP/162241/2005 Rev. 3. 2022.
Li Y., Shen Y., Yao C.L., Guo D.A. Quality assessment of herbal medicines based on chemical fingerprints combined with chemometrics approach: A review. Journal of Pharmaceutical and Biomedical Analysis. 2020;185:113215. DOI: 10.1016/j.jpba.2020.113215.
Noviana E., Indrayanto G., Rohman A. Advances in fingerprint analysis for standardization and quality control of herbal medicines. Frontiers in Pharmacology. 2022;13:853023. DOI: 10.3389/fphar.2022.853023.