Red Clover Tablets, chemical structure, molecular formula, Reference Standards

Red Clover Tablets

»Red Clover Tablets contain Powdered Red Clover Extract.Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of Powdered Extract calculated as isoflavones.

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

Labeling— The label states the Latin binomial and,following the official name,the article from which Tablets were prepared.The label also indicates the quantity,in mg,of Powdered Extract per Tablet.Label Tablets to indicate the content,in mg,of isoflavones per 100mg of Powdered Extract.

USP Reference standards á11ñ— USP Formononetin RS.USP Powdered Red Clover Extract RS.

Identification— The chromatogram of the Test solutionexhibits peaks for daidzein,genistein,formononetin,and biochanin Aat retention times that correspond to those in the chromatogram of Standard solution 1,as obtained in the test for Content of isoflavones.Calculate the ratio of 5,7-dihydroxyisoflavones to 7-hydroxyisoflavones by the formula:

(B+G)/(D+F),

in which B,G,D,andFare the contents of biochanin A,genistein,daidzein,and formononetin,respectively,as obtained in the test for Content of isoflavones:the ratio is between 0.1and 10.0.

Microbial enumeration á2021ñ— It meets the requirements of the tests for absence of Salmonellaspecies and Escherichia coli.The total aerobic microbial count does not exceed 104cfu per g,the total combined molds and yeasts count does not exceed 103cfu per g,and the enterobacterial count is not less than 103cfu per g.

Disintegration á2040ñ: meet the requirements for disintegration of botanical dosage forms.

Weight variation á2091ñ: meet the requirements.

Content of isoflavones—

Solvent,Solution A,Solution B,Mobile phase,Standard solution 1,Standard solution 2,and Chromatographic system— Proceed as directed in the test forContent of isoflavones underRed Clover.

Test solution— Accurately weigh not fewer than 20Tablets,and pulverize,using a mortar and pestle.Transfer an accurately weighed quantity of the powder,equivalent to 40mg of the labeled amount of isoflavones,to a 250-mLvolumetric flask.Add 15mLof water,shake to disperse the powder,add 15mLof dehydrated alcohol and about 200mLof Solvent,and sonicate for 30minutes.If dark particles are present in the bottom of the flask,sonicate again for an additional 10minutes or until they disappear.Cool to room temperature,and dilute with Solventto volume.Transfer 50.0mLof the resulting solution to a round-bottom flask,and evaporate to dryness under vacuum.Add 15mLof 2Nhydrochloric acid,and heat in a water bath for 30minutes.Quantitatively transfer this solution with the aid of about 15mLof alcohol,to a 50-mLvolumetric flask,and dilute with Solvent to volume.Pass 5mLof the solution through a filter having a 0.45-µm porosity,discarding the first 4mLof the filtrate.Collect the remaining 1mLof filtrate for testing.

Procedure— Proceed as directed in the test for Content of isoflavonesunderRed Clover.Calculate the content of isoflavones,in mg,in the portion of Tablets taken by the formula:

250FC(rU/rS),

in which the terms are as defined therein.

Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist

Expert Committee:(DSB)Dietary Supplements:Botanicals

USP28–NF23Page 2073

Pharmacopeial Forum:Volume No.28(3)Page 812

Phone Number:1-301-816-8343