Document Type
Oral Presentation
Location
Oxford Convention Center, 102 Ed Perry Boulevard Oxford, MS 38655
Event Website
https://oxfordicsb.org/
Start Date
15-4-2024 1:15 PM
End Date
15-4-2024 1:30 PM
Description
Dietary supplement current good manufacturing practice (cGMP) in the U.S. requires the 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 using scientifically valid methods of analysis. However, specifications for botanical extracts (including fungal and algal extracts) routinely include additional data that are not amenable to verification through analytical methods. 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 starting raw material (as 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.” In addition, Plant to Extract ratios are often misused as a measure of extract strength for dosage calculations. This oral presentation covers the effort of the USP Botanical Dietary Supplements and Herbal Medicine Expert Committee to clarify the meaning of Plant to Extract ratios that resulted in the Frontiers publication “Understanding plant to extract ratios in botanical extracts”, Front Pharmacol. 2022; 13: 981978 (https://doi.org/10.3389/fphar.2022.981978). Examples of common misconceptions will be provided, and special emphasis will be given to the proper use of Plant to Extract ratios in describing and labeling botanical extract ingredients and finished products.
Recommended Citation
Monagas, Maria; Brendler, Thomas; Brinckmann, Josef; Dentali, Steven; Gafner, Stefan; Giancaspro, Gabriel; Johnson, Holly; Kababick, James; Ma, Cuiying; Oketch-Rabah, Hellen; Pais, Pilar; Sarma, Nandu; and Marles, Robin, "Understanding Plant to Extract Ratios of Botanical Extracts and Their Implications in Product Labeling" (2024). Oxford ICSB. 4.
https://egrove.olemiss.edu/icsb/2024_ICSB/Schedule/4
Publication Date
April 2024
Accessibility Status
Searchable text
Included in
Understanding Plant to Extract Ratios of Botanical Extracts and Their Implications in Product Labeling
Oxford Convention Center, 102 Ed Perry Boulevard Oxford, MS 38655
Dietary supplement current good manufacturing practice (cGMP) in the U.S. requires the 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 using scientifically valid methods of analysis. However, specifications for botanical extracts (including fungal and algal extracts) routinely include additional data that are not amenable to verification through analytical methods. 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 starting raw material (as 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.” In addition, Plant to Extract ratios are often misused as a measure of extract strength for dosage calculations. This oral presentation covers the effort of the USP Botanical Dietary Supplements and Herbal Medicine Expert Committee to clarify the meaning of Plant to Extract ratios that resulted in the Frontiers publication “Understanding plant to extract ratios in botanical extracts”, Front Pharmacol. 2022; 13: 981978 (https://doi.org/10.3389/fphar.2022.981978). Examples of common misconceptions will be provided, and special emphasis will be given to the proper use of Plant to Extract ratios in describing and labeling botanical extract ingredients and finished products.
https://egrove.olemiss.edu/icsb/2024_ICSB/Schedule/4