Understanding plant to extract ratios in botanical extracts
- PMID: 36249773
- PMCID: PMC9561911
- DOI: 10.3389/fphar.2022.981978
Understanding plant to extract ratios in botanical extracts
Abstract
Dietary supplement current good manufacturing practice (cGMP) requires establishment of quality parameters for each component used in the manufacture of a dietary supplement to ensure that specifications for the identity, purity, strength, composition, and limits on contaminants are met. Compliance with botanical extract ingredient specifications is assured by using scientifically valid methods of analysis, the results of which are reported on certificates of analysis (CoAs). However, CoAs routinely include additional data that are not amenable to verification through methods of analysis. Such descriptive information may include Plant to Extract ratios, which are ratios of the quantity of botanical article used in the manufacture of the extract to the quantity of extract obtained. Plant to Extract ratios can be misleading when their meaning is not clearly understood. Plant to Extract ratios do not completely describe botanical extracts because other important factors influence the make-up of final extracts, such as the quality of the raw starting material (as can defined by pharmacopeial standards), extraction solvent(s) used, duration and temperature of extraction, and percentage and type of excipients present. Other important qualitative descriptions may include constituent "fingerprinting." Despite these issues, Plant to Extract ratios are often used as a measure of extract strength for dosage calculations. This article defines and clarifies the meaning of Plant to Extract ratios and their proper use in describing and labeling botanical extract ingredients and finished products containing them.
Keywords: botanical extract; drug to extract ratio (DER); genuine extract; herbal medicine; native extract; plant to extract ratio.
Copyright © 2022 Monagas, Brendler, Brinckmann, Dentali, Gafner, Giancaspro, Johnson, Kababick, Ma, Oketch-Rabah, Pais, Sarma and Marles.
Conflict of interest statement
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Figures
References
-
- American Herbal Products Association (2000). AHPA guidance policy. Retail labeling of dietary supplements containing soft or powdered botanical extracts. Available at: https://www.ahpa.org/Portals/0/PDFs/Policies/Guidance-Policies/AHPA_Reta... .
-
- American Herbal Products Association (2021). FAQs about herbal products. Available at: http://www.ahpa.org/Consumers/HerbalFAQ.aspx .
-
- American Herbal Products Association (2003). Standardization of botanical products: White paper. Available at: http://www.ahpa.org/News/LatestNews/TabId/96/ArtMID/1179/ArticleID/225/W... .
-
- Australian Government. Department of Health (2011). Therapeutic goods administration. Guidance on equivalence of herbal extracts in complementary medicines. Available at: https://www.tga.gov.au/publication/guidance-equivalence-herbal-extracts-... .
-
- Australian Government. Department of Health (2021). Therapeutic goods administration. Medicine labels. Guidance on TGO 91 and TGO 92. Version 2.3 Available at: https://www.tga.gov.au/medicine-labels-guidance-tgo-91-and-tgo-92 .
Publication types
LinkOut - more resources
Full Text Sources
Other Literature Sources
Miscellaneous
