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 senticosusHarms]extracted with hydroalcoholic mixtures.The ratio of the starting crude plant material to Powdered Extract is between 13:1and 25:1.It contains not less than 0.8percent of eleutherosides Band 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 Labelingunder Botanical Extracts á565ñ.
Thin-layer chromatographic identification test á201ñ—
Test solution— Transfer about 500mg of Powdered Extract to a round-bottom flask,add 50mLof alcohol 30%(v/v),and heat under reflux for 10minutes.Cool at room temperature,filter,gently evaporate the solution to dryness,and suspend the residue in 5mLof methanol.
Standard solution,Developing solvent system,Spray reagent,and Procedure— Proceed as directed for Identificationunder Eleuthero.
Water,Method Ia á921ñ: not more than 5.0%.
Total ash á561ñ: not more than 10.0%.
Heavy metals,Method IIá231ñ: not more than 0.002%.
Organic volatile impurities,Method IVá467ñ: meets the requirements.
Solvent: dimethyl sulfoxide.
Alcohol content,Method IIá611ñ: not more than 0.5%.
Content of eleutherosides Band E—
Solvent,Solution A,Solution B,Mobile phase,Standard solution,and Chromatographic system— Proceed as directed for Content of eleutherosides Band Eunder Eleuthero.
Test solution— Transfer about 500mg of Powdered Extract,accurately weighed,to a 100-mLvolumetric flask,add 80mLof Solvent,and sonicate for 30minutes.Cool to room temperature,and dilute with Solventto volume.Pass the solution through a filter having a 0.45-µm or finer porosity.
Procedure— Proceed as directed for Content of eleutherosides Band Eunder Eleuthero.Separately calculate the percentage of eleutheroside Band eleutheroside Ein the portion of Powdered Extract taken by the formula:
100P(C/W)(rU/rS),
in which Wis 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 Band Ein the portion of Powdered Extract taken by adding the individual percentages.
Other requirements— It meets the requirements for Residual Solventsand Pesticide Residuesunder Botanical Extracts á565ñ.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 2085
Pharmacopeial Forum:Volume No.26(6)Page 1599
Phone Number:1-301-816-8343