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

Powdered Echinacea pallida Extract

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»Powdered Echinacea pallidaExtract is prepared from Echinacea pallidaroots by 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 and not more than 5.0percent of total phenols,calculated as the sum of caftaric acid (C13H12O9),chicoric acid (C22H18O12),chlorogenic acid (C16H18O9),

USP28and echinacoside (C35H46O20)

on the dried basis.

USP28

Packaging and storage— Preserve in tight,light-resistant containers,and store 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.

The label bears a statement indicating that Echinacea pallida 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 pallida Extract RS.

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Identification—

A:Thin-Layer Chromatographic Identification Test á201ñ—

Standard solution 2,Developing solvent system,Spray reagent 1,Spray reagent 2,and Procedure— Proceed as directed for Identificationtest Aunder Echinacea angustifolia.

Test solution— Dissolve

1.0

USP28g of Powdered Extract in 10mLof methanol.Allow to settle before use.

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

100

USP28mg per mL.

B: The retention time of the major peak in the chromatogram of the Test solutioncorresponds to that of the echinacoside peak 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,and Standard solution 2— Proceed as directed for Content of total phenolsunder Echinacea angustifolia.

Standard solution 1— Proceed as directed for Content of total phenolsunder Echinacea angustifolia,except to use USP Powdered Echinacea pallidaExtract RSinstead of USP Powdered Echinacea angustifoliaExtract RS.

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

an appropriate round-bottom flask equipped with a condenser.

USP28Add 25.0mLof 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.

Chromatographic system— Prepare as directed for Content of total phenolsunder Echinacea angustifolia.Chromatograph Standard solution 1,and record the peak responses as directed for Procedure:the chromatogram obtained is similar to the Reference Chromatogram for total phenols provided with USP Powdered Echinacea pallidaExtract RS.Chromatograph Standard solution 2,and record the peak responses as directed for Procedure:the capacity factor,k¢,is not less than

3.0;

USP28the tailing factor is not more than 2.0;and the relative standard deviation for replicate injections is not more than 2.5%.

Procedure— Proceed as directed for Content of total phenolsunder Echinacea angustifolia.Separately 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;and 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 calculated.

Other requirements— It meets the requirements of the tests 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 2079

Pharmacopeial Forum:Volume No.30(2)Page 556

Phone Number:1-301-816-8343