Add the following:
American Ginseng Tablets
»American Ginseng Tablets contain Powdered American Ginseng Extract.Tablets contain not less than 90.0percent and not more than 110.0percent of Extract,calculated as the sum of ginsenosides Rg1,Re,Rb1,Rc,Rb2,and Rd.
Packaging and storage— Preserve in tight containers,protected from light.Store at controlled room temperature.
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 Extract,in mg per Tablet.Label the Tablets to indicate the percentage of total ginsenosides in the Extract contained in the Tablets.
USP Reference standards— USP Powdered American Ginseng Extract RS.
Identification—
A: Proceed as directed for Identification Aunder American Ginseng,using the following Test solution.
Test solution— Reduce the Tablets to a very fine powder.Transfer a quantity of the powder,equivalent to about 100mg of Extract,to a conical flask.Extract at 55with three 20-mLportions of a mixture of water and methanol (8:2).Evaporate the combined extracts to dryness under vacuum at 45to 50.Dissolve the residue in 5mLof methanol.
B: The retention times of the peaks for ginsenosides Rg1,Re,Rb1,Rb2,Rc2,and Rd in the chromatogram of the Test solutioncorrespond to those in the chromatogram of Standard solution 1,as obtained in the test for Content of ginsenosidesunder American Ginseng.The ratio of the peak reaponse for Rb2to the peak response for Rb1is less than 0.4;and the ratio of the peak response for Rg1to the peak response for Rb1is less than 0.3.The chromatogram shows no significant peak at the retention time corresponding to that of the RFfor ginsenoside in the chromatogram of Standard solution 2,as obtained in the test for Content of ginsenosides under American Ginseng.
Microbial enumeration á2021ñ— The total aerobic microbial count does not exceed 104cfu per g.The total combined molds and yeasts count does not exceed 1000cfu per g.It meets the requirements of the tests for absence of Salmonellaspecies and Escherichia coli.
Disintegration á2040ñ: meet the requirements.
Weight variation á2091ñ: meet the requirements.
Content of ginsenosides—
Mobile phase andChromatographic system— Proceed as directed for the Content of ginsenosidesunder American Ginseng.
Standard solution— Prepare a solution of USP Powdered American Ginseng Extract RSin a mixture of water and alcohol (6:4)having a known concentration of about 1mg of Rb1per mL.
Test solution— Accurately weigh not fewer than 20Tablets,and reduce to a very fine powder.To a conical flask,transfer an accurately weighed portion of the powder expected to contain an amount of Extract equivalent to about 15mg of total ginsenosides.Add 15mLof methanol,and shake to mix.Sonicate the mixture at 25to 30for 30minutes.Cool,pass through filter paper,and return the residue to the conical flask.Add another 15mLof methanol,sonicate the mixture at 25to 30for 30minutes,and filter.Wash the residue with three 15-mLportions of methanol.Evaporate the combined extracts and washings to dryness under vacuum at 45to 50.Quantitatively transfer the residue to a 10.0-mLvolumetric flask,using small volumes of methanol,and dilute with methanol to volume.
Procedure— Proceed as directed for Procedure in the test for Content of ginsenosidesunder American Ginseng.Separately calculate the quantity,in mg,of each relevant ginsenoside (Rg1,Re,Rb1,Rc,Rb2,and Rd)in the portion of Tablets taken to prepare the Test solution by the formula:
0.1PC(rU/rS),
in which Cis the concentration,in mg per mL,of USP Powdered American Ginseng Extract RSin the Standard solution;Pis the labeled content of the corresponding ginsenoside in the USP Powdered American Ginseng Extract RS;and rUand rSare the peak responses of the relevant ginsenosides obtained from the Test solution and the Standard solution,respectively.Calculate the content of ginsenosides as the sum of the individual quantities of Rg1,Re,Rb1,Rc,Rb2,and Rd.USP28
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 2097
Pharmacopeial Forum:Volume No.30(2)Page 567
Phone Number:1-301-816-8343