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Powdered Eleuthero Extract
» Powdered Eleuthero Extract is prepared from whole or comminuted dried underground parts of Eleutherococcus senticosus (Rupr. et Maxim.) (Fam. Araliaceae) [Syn: Acanthopanax senticosus Harms] extracted with hydroalcoholic mixtures. The ratio of the starting crude plant material to Powdered Extract is between 13:1 and 25:1. It contains not less than 0.8 percent of eleutherosides B and E, calculated on the anhydrous basis. It may contain added substances.
Packaging and storage— Preserve in tight, light-resistant containers.
Labeling— The label states the Latin binomial and, following the official name, the part of the plant from which the article was prepared. The label also indicates the content of eleutherosides, the extracting solvent used for preparation, and the ratio of the starting crude plant material to Powdered Extract. It meets the requirements for Labeling under Botanical Extracts 565.
Thin-layer chromatographic identification test 201—
Test solution— Transfer about 500 mg of Powdered Extract to a round-bottom flask, add 50 mL of alcohol 30% (v/v), and heat under reflux for 10 minutes. Cool at room temperature, filter, gently evaporate the solution to dryness, and suspend the residue in 5 mL of methanol.
Standard solution, Developing solvent system, Spray reagent, and Procedure— Proceed as directed for Identification under Eleuthero.
Water, Method Ia 921: not more than 5.0%.
Total ash 561: not more than 10.0%.
Heavy metals, Method II 231: not more than 0.002%.
Organic volatile impurities, Method IV 467: meets the requirements.
Solvent: dimethyl sulfoxide.
Alcohol content, Method II 611: not more than 0.5%.
Content of eleutherosides B and E—
Solvent, Solution A, Solution B, Mobile phase, Standard solution, and Chromatographic system— Proceed as directed for Content of eleutherosides B and E under Eleuthero.
Test solution— Transfer about 500 mg of Powdered Extract, accurately weighed, to a 100-mL volumetric flask, add 80 mL of Solvent, and sonicate for 30 minutes. Cool to room temperature, and dilute with Solvent to volume. Pass the solution through a filter having a 0.45-µm or finer porosity.
Procedure— Proceed as directed for Content of eleutherosides B and E under Eleuthero. Separately calculate the percentage of eleutheroside B and eleutheroside E in the portion of Powdered Extract taken by the formula:
100P(C/W)(rU / rS),
in which W is the weight, in mg, of Powdered Eleuthero Extract in the Test solution; and the other terms are as defined therein. Calculate the percentage of eleutherosides B and E in the portion of Powdered Extract taken by adding the individual percentages.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements for Residual Solvents and Pesticide Residues under Botanical Extracts 565.
Auxiliary Information— Staff Liaison : Maged H. Sharaf, Ph.D., Senior Scientist
Expert Committee : (DSB05) Dietary Supplements - Botanicals
USP29–NF24 Page 2324
Pharmacopeial Forum : Volume No. 26(6) Page 1599
Phone Number : 1-301-816-8318