Packaging and storage—
Preserve in tight containers, protected from light.
Labeling—
The label states the Latin binomial and, following the official name, the article from which the Tablets were prepared. The label also indicates the amount of Powdered Extract, in mg per Tablet, and the content, in mg, of ginsenosides per 100 mg of Powdered Extract.
Identification—
A:
Thin-Layer Chromatographic Identification Test 
201
—
Test solution—
Powder and transfer a portion of Tablets, equivalent to about 100 mg of Powdered Extract, to a conical flask, and extract three times, each with a 20-mL portion of a mixture of methanol and water (8:2), in a 55
bath for 30 minutes, stirring with a magnetic stirrer. Evaporate the combined extracts to dryness in vacuum between 45
and 50
, and dissolve the residue in 10 mL of a mixture of methanol and water (15:10).
Standard solution, Application volume, Developing solvent system, Spray reagent, and Procedure—
Proceed as directed for Identification test A under Asian Ginseng.
B:
The retention times of the relevant analytes in the chromatogram of the Test solution correspond to those in the chromatogram of the Standard solution, as obtained in the test for Content of ginsenosides. The retention time of the peak for ginsenoside Rf in the chromatogram of the Test solution corresponds to that in the chromatogram of the Standard solution, as obtained in the test for Content of ginsenosides.
Microbial enumeration 2021—
The total aerobic microbial count does not exceed 10
4 cfu per g, and the total combined molds and yeasts count does not exceed 1000 cfu per g. Tablets meet the requirements of the tests for absence of
Salmonella species and
Escherichia coli.
Content of ginsenosides—
Solution A, Solution B, Mobile phase, and Chromatographic system—
Proceed as directed for Content of ginsenosides under Powdered Asian Ginseng Extract.
Standard solution—
Transfer about 200 mg of
USP Powdered Asian Ginseng Extract RS, accurately weighed, to a suitable container, dissolve in 5.0 mL of a mixture of water and alcohol (6:4), and filter.
Test solution—
Weigh and powder not fewer than 20 Tablets. Transfer an accurately weighed amount of the powder, equivalent to about 200 mg of Powdered Extract, to a conical flask, and extract three times, each with a 20-mL portion of a mixture of methanol and water (8:2), in a 55
bath for 30 minutes, stirring with a magnetic stirrer. Evaporate the combined extracts to dryness in vacuum between 45
and 50
. Dissolve the residue in 5.0 mL of a mixture of water and alcohol (6:4), and filter.
Procedure—
Proceed as directed for
Content of ginsenosides under
Powdered Asian Ginseng Extract, except to calculate the quantity, in mg, of each relevant ginsenoside (Rg
1, Re, Rb
1, Rc, Rb
2, and Rd) in the portion of Tablets taken by the formula:
0.05PC(rU / rS),
in which
C is the concentration, in mg per mL, of
USP Powdered Asian Ginseng Extract RS in the
Standard solution; and the other terms are as defined therein. Calculate the quantity, in mg, of ginsenosides by adding the individual amounts calculated as above.
Auxiliary Information—
Staff Liaison :
Maged H. Sharaf, Ph.D., Senior Scientist
Expert Committee : (DSB05) Dietary Supplements - Botanicals
USP29–NF24 Page 2340
Pharmacopeial Forum : Volume No. 30(2) Page 573
Phone Number : 1-301-816-8318
