Understanding plant to extract ratios in botanical extracts
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...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-09-01
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| Series: | Frontiers in Pharmacology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2022.981978/full |
| _version_ | 1811207293746806784 |
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| author | Maria Monagas Thomas Brendler Josef Brinckmann Steven Dentali Stefan Gafner Gabriel Giancaspro Holly Johnson James Kababick Cuiying Ma Hellen Oketch-Rabah Pilar Pais Nandu Sarma Robin Marles |
| author_facet | Maria Monagas Thomas Brendler Josef Brinckmann Steven Dentali Stefan Gafner Gabriel Giancaspro Holly Johnson James Kababick Cuiying Ma Hellen Oketch-Rabah Pilar Pais Nandu Sarma Robin Marles |
| author_sort | Maria Monagas |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-12T04:01:54Z |
| format | Article |
| id | doaj.art-8a2b5f3b78244515986681f06a563586 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-12T04:01:54Z |
| publishDate | 2022-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-8a2b5f3b78244515986681f06a5635862022-12-22T03:48:42ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-09-011310.3389/fphar.2022.981978981978Understanding plant to extract ratios in botanical extractsMaria Monagas0Thomas Brendler1Josef Brinckmann2Steven Dentali3Stefan Gafner4Gabriel Giancaspro5Holly Johnson6James Kababick7Cuiying Ma8Hellen Oketch-Rabah9Pilar Pais10Nandu Sarma11Robin Marles12United States Pharmacopeia (USP). Dietary Supplements and Herbal Medicines, Rockville, MD, United StatesUnited States Pharmacopeia (USP). Botanical Dietary Supplements and Herbal Medicines Expert Committee, Rockville, MD, United StatesUnited States Pharmacopeia (USP). Botanical Dietary Supplements and Herbal Medicines Expert Committee, Rockville, MD, United StatesUnited States Pharmacopeia (USP). Botanical Dietary Supplements and Herbal Medicines Expert Committee, Rockville, MD, United StatesUnited States Pharmacopeia (USP). Botanical Dietary Supplements and Herbal Medicines Expert Committee, Rockville, MD, United StatesUnited States Pharmacopeia (USP). Dietary Supplements and Herbal Medicines, Rockville, MD, United StatesUnited States Pharmacopeia (USP). Botanical Dietary Supplements and Herbal Medicines Expert Committee, Rockville, MD, United StatesUnited States Pharmacopeia (USP). Botanical Dietary Supplements and Herbal Medicines Expert Committee, Rockville, MD, United StatesUnited States Pharmacopeia (USP). Dietary Supplements and Herbal Medicines, Rockville, MD, United StatesUnited States Pharmacopeia (USP). Dietary Supplements and Herbal Medicines, Rockville, MD, United StatesUnited States Pharmacopeia (USP). Botanical Dietary Supplements and Herbal Medicines Expert Committee, Rockville, MD, United StatesUnited States Pharmacopeia (USP). Dietary Supplements and Herbal Medicines, Rockville, MD, United StatesUnited States Pharmacopeia (USP). Botanical Dietary Supplements and Herbal Medicines Expert Committee, Rockville, MD, United StatesDietary 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.https://www.frontiersin.org/articles/10.3389/fphar.2022.981978/fullbotanical extractgenuine extractnative extractplant to extract ratioherbal medicinedrug to extract ratio (DER) |
| spellingShingle | Maria Monagas Thomas Brendler Josef Brinckmann Steven Dentali Stefan Gafner Gabriel Giancaspro Holly Johnson James Kababick Cuiying Ma Hellen Oketch-Rabah Pilar Pais Nandu Sarma Robin Marles Understanding plant to extract ratios in botanical extracts Frontiers in Pharmacology botanical extract genuine extract native extract plant to extract ratio herbal medicine drug to extract ratio (DER) |
| title | Understanding plant to extract ratios in botanical extracts |
| title_full | Understanding plant to extract ratios in botanical extracts |
| title_fullStr | Understanding plant to extract ratios in botanical extracts |
| title_full_unstemmed | Understanding plant to extract ratios in botanical extracts |
| title_short | Understanding plant to extract ratios in botanical extracts |
| title_sort | understanding plant to extract ratios in botanical extracts |
| topic | botanical extract genuine extract native extract plant to extract ratio herbal medicine drug to extract ratio (DER) |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2022.981978/full |
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