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test method for Red Clover Extract |
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Origin: USP |
Show: 536 |
Time: 2009-2-5 23:13:53 |
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Powdered Red Clover Extract
»Powdered Red Clover Extract is prepared from Red Clover by extraction with hydroalcoholic mixtures or other suitable solvents.The ratio of plant material to extract is between 3:1and 25:1.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of isoflavones,calculated on the dried basis as the sum of daidzein,genistein,formononetin,and biochanin A.It may contain suitable added substances.
Packaging and storage¡ª Preserve in tight,light-resistant containers,in a cool place.
Labeling¡ª 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 isoflavones,the extracting solvent or solvent mixture used for preparation,and the ratio of the starting crude plant material to Powdered Extract.It meets the requirements for labeling under Botanical Extracts ¨¢565ñ.
Identification¡ª
B: 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 percentages 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 ¨¢2021ñ¡ª 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 1000cfu per g,and the enterobacterial count is not more than 1000cfu per g.
Content of isoflavones¡ª
Solvent,Solution A,Solution B,Standard solution 1,Standard solution 2,andChromatographic system¡ª Proceed as directed under Red Clover.
Test solution¡ª Transfer an accurately weighed quantity of Powdered Extract,equivalent to about 30mg of the labeled content of isoflavones,to a 250-mLvolumetric flask.Add 15mLof dehydrated alcohol,sonicate until dissolved,dilute with Solventto volume,and mix.Transfer 50.0mLof this 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 the resulting solution with the aid of about 15mLof alcohol to a 50-mLvolumetric flask,and dilute with Solventto volume.Centrifuge,or pass through a filter having a 0.45-µm or finer porosity.
Procedure¡ª Proceed as directed under Red Clover.Separately calculate the percentage of each relevant isoflavone component in the portion of Powdered Extract taken by the formula:
25F(C/W)(rU/rS), in which Wis the weight,in g,of Powdered Extract taken to prepare the Test solution;and the other terms are as defined therein.Calculate the percentage of isoflavones in the Powdered Extract taken by adding the individual quantities calculated. |
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