Packaging and storage—
Preserve in tight, light-resistant containers, in a cool place.
Labeling—
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 
565
.
Identification—
B:
The chromatogram of the
Test solution exhibits peaks for daidzein, genistein, formononetin, and biochanin A at 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
F are the percentages of biochanin A, genistein, daidzein, and formononetin, respectively, as obtained in the test for
Content of isoflavones: the ratio is between 0.1 and 10.0.
Microbial enumeration 2021—
It meets the requirements of the tests for absence of
Salmonella species and
Escherichia coli. The total aerobic microbial count does not exceed 10
4 cfu per g, the total combined molds and yeasts count does not exceed 1000 cfu per g, and the enterobacterial count is not more than 1000 cfu per g.
Content of isoflavones—
Solvent, Solution A, Solution B, Standard solution 1, Standard solution 2, and Chromatographic system—
Proceed as directed under
Red Clover.
Test solution—
Transfer an accurately weighed quantity of Powdered Extract, equivalent to about 30 mg of the labeled content of isoflavones, to a 250-mL volumetric flask. Add 15 mL of dehydrated alcohol, sonicate until dissolved, dilute with Solvent to volume, and mix. Transfer 50.0 mL of this solution to a round-bottom flask, and evaporate to dryness under vacuum. Add 15 mL of 2 N hydrochloric acid, and heat in a water bath for 30 minutes. Quantitatively transfer the resulting solution with the aid of about 15 mL of alcohol to a 50-mL volumetric flask, and dilute with Solvent to volume. Centrifuge, or pass through a filter having a 0.45-µm or finer porosity.
Procedure—
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
W is 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.
Other requirements—
It meets the requirements for
Packaging and Storage, Residual Solvents, and
Pesticide Residues under
Botanical Extracts 565.
Auxiliary Information—
Staff Liaison :
Maged H. Sharaf, Ph.D., Senior Scientist
Expert Committee : (DSB05) Dietary Supplements - Botanicals
USP29–NF24 Page 2310
Pharmacopeial Forum : Volume No. 30(2) Page 552
Phone Number : 1-301-816-8318
for 2 hours. It loses not more than 5.0%.