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.
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,and
Fare 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 10
4cfu per g,the total combined molds and yeasts count does not exceed 10
3cfu per g,and the enterobacterial count is not less than 10
3cfu per g.
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 for
Content of isoflavones under
Red 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 isoflavonesunder
Red 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.