Powdered Echinacea purpurea Extract, chemical structure, molecular formula, Reference Standards

Powdered Echinacea purpurea Extract

Change to read:

»Powdered Echinacea purpureaExtract is prepared from dried Echinacea purpureaRoot,

Echinacea purpureaAerial Parts,or a mixture of them,

USP28by extraction with hydroalcoholic mixtures or other suitable solvents.The ratio of the starting crude plant material to Powdered Extract is between 2:1and 8:1.It contains not less than 4.0percent of total phenols,calculated

USP28as the sum of caftaric acid (CH1312O9),chicoric acid (C22H18O12),chlorogenic acid (C16H18O9),and echinacoside (C35H46O20)

on the dried basis.

USP28It contains not less than 0.025percent of

dodecatetraenoic acid isobutylamides (C16H25NO),

USP28calculated on the dried basis.

USP28

Packaging and storage— Preserve in tight,light-resistant containers,in a cool place.

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Labeling— The label states the Latin binomial and,following the official name,the parts of the plant from which the article was prepared.

If derived from root and aerial parts,indicate the corresponding percentages.Label it to indicate the content of total phenols and dodecatetraenoic isobutylamides.The label bears a statement indicating that Echinacea purpurea may cause rare allergic reactions,rashes,or aggravate asthma.

USP28It meets the requirements for Labelingunder Botanical Extracts á565ñ.

USP Reference standards á11ñ— USP Chlorogenic Acid RS.USP Powdered Echinacea purpurea Extract RS.USP2E,4E-Hexadienoic Acid Isobutylamide RS.

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Identification—

A:Thin-Layer Chromatographic Identification Test á201ñ—

Test solution— Weigh and finely pulverize about 10g of Powdered Extract,and transfer 1g of the powder to a suitable extraction thimble.Transfer the thimble to a continuous extraction apparatus,and extract with 50mLof chloroform for 1hour.Evaporate the chloroform extract to dryness at 40

in vacuum.To the residue,add 1mLof alcohol,and pass through a nylon membrane filter having a porosity of 0.45µm.

Standard solution 1— Dissolve an accurately weighed quantity of USP Powdered Echinacea purpureaExtract RSin methanol to obtain a solution having a known concentration of about

100

USP28mg per mL.

Standard solution 2,Developing solvent system,Spray reagent,and Procedure— Proceed as directed for Identificationtest Bunder Echinacea angustifolia.

B: The retention times of the peaks for chicoric and caftaric acids in the chromatogram of the Test solutioncorrespond to those in the chromatogram of Standard solution 1,as obtained in the test for Content of total phenols.

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Content of total phenols—

Solvent,Solution A,Solution B,Mobile phase,Standard solution 2,and Chromatographic system— Proceed as directed for Content of total phenolsunder Echinacea angustifolia.

Standard solution 1— Dissolve an accurately weighed quantity of USP Powdered Echinacea purpureaExtract RSin Solvent,shaking for 1minute,and dilute with Solventto obtain a solution having a known concentration of about 5mg per mL.Pass through a membrane filter having a 0.45-µm or finer porosity.

Test solution— Transfer about 60mg of Powdered Extract,accurately weighed,to a

suitable round-bottom flask equipped with a condenser.

USP28Add 25mLof Solvent,and

heat under reflux while shaking

USP28by mechanical means for 15minutes.Centrifuge,or pass through a membrane filter having a 0.45-µm or finer porosity.

Procedure— Proceed as directed in the test for Content of total phenolsunder Echinacea purpurea Root.Calculate the percentage of each relevant component of total phenols in the portion of Powdered Extract taken by the formula:

2500F(C/W)(ri/rS),

in which Fis the response factor and is equal to 0.695for chicoric acid,0.881for caftaric acid,1.000for chlorogenic acid,and 2.220for echinacoside;Cis the concentration,in mg per mL,of USP Chlorogenic Acid RSin Standard solution 2;Wis the weight,in mg,of the portion of Powdered Extract taken;riand rSare the peak responses for the relevant analyte obtained from the Test solutionand Standard solution 2,respectively.Calculate the percentage of total phenols in the portion of Powdered Extract taken by adding the individual percentages.

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Content of

dodecatetraenoic acid isobutylamides—

USP28

Mobile phase and Standard solution 2— Proceed as directed for Content of dodecatetraenoic acid isobutylamidesunder Echinacea angustifolia.

Standard solution 1— Proceed as directed for Content of dodecatetraenoic acid isobutylamidesunder Echinacea angustifolia,except to use USP Powdered Echinacea purpureaExtract RSinstead of USP Powdered Echinacea angustifoliaExtract RS.

Test solution— Proceed as directed for Content of dodecatetraenoic acid isobutylamidesunder Echinacea angustifolia,except to use Powdered Echinacea purpureaExtract instead of Powdered Echinacea angustifoliaExtract.

Chromatographic system— Proceed as directed for Content of dodecatetraenoic acid isobutylamidesunder Echinacea angustifolia,except to use the Reference Chromatogram for alkamides provided with USP Powdered Echinacea purpureaExtract RSinstead of the Reference Chromatogram provided with USP Powdered Echinacea angustifoliaExtract RS.

Procedure— Proceed as directed in the test for Content of dodecatetraenoic acid isobutylamides under Echinacea angustifolia.Calculate the percentage of

dodecatetraenoic acid isobutylamides

USP28in the portion of Powdered Extract taken by the formula:

10(1.353)(C/W)(ri/rS),

in which 1.353is the response factor for 2E,4E-hexadienoic acid isobutylamide;Cis the concentration,in mg per mL,of USP2E,4E-Hexadienoic Acid Isobutylamide RSin Standard solution 2;Wis the weight,in g,of the portion of Powdered Extract taken;riis the sum of the peak responses of the relevant analytes obtained from the Test solution;and rSis the peak response obtained from Standard solution 2.

Other requirements— It meets the requirements for Microbial enumeration,Loss on drying,Heavy metals,and Organic volatile impuritiesunder Powdered Echinacea angustifolia Extract,and 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 2083

Pharmacopeial Forum:Volume No.30(2)Page 561

Phone Number:1-301-816-8343