Powdered Asian Ginseng Extract
»Powdered Asian Ginseng Extract is prepared from Asian Ginseng by maceration,percolation,or both processes performed at room temperature with suitable solvents such as alcohol,methanol,water,or mixtures of these solvents,and by concentrating the fluidextract at temperatures below 50.The ratio of the starting crude plant material to Powdered Extract is between 3:1and 7:1.It contains not less than 3.0percent of ginsenosides Rg1,Re,Rb1,Rc,Rb2,and Rd combined,calculated on the anhydrous basis.It may contain other added substances.
Identification—
A: Thin-Layer Chromatographic Identification Test á201ñ—
Adsorbent: 0.2-mm layer of chromatographic silica gel mixture on a high-performance thin-layer chromatographic plate.
Extraction column— Use a solid-phase extraction column that contains packing L1with a sorbent mass to column volume ratio of 360mg per 0.85mL,or equivalent.Condition the column prior to use by washing with 3mLof methanol and with 8mLof water.
Test solution— Transfer about 1.0g of Powdered Extract,accurately weighed,to a 25-mLvolumetric flask,and dissolve in water,sonicating if necessary.Dilute with water to volume,and mix.Transfer 4.0mLof this solution to the Extraction column,wash with 10mLof water,and discard the eluate.Elute the column with 2mLof methanol,and collect the eluate in a suitable vial.
Standard solution— Transfer about 0.1g of USP Powdered Asian Ginseng Extract RS,accurately weighed,to a 5-mLvolumetric flask,and proceed as directed for Test solution,beginning with “dissolve in water”.
Developing solvent system: a mixture of chloroform,methanol,and water (65:35:10).Use the lower phase.
Spray reagent: a mixture of alcohol,acetic anhydride,and sulfuric acid (18:1:1).
Procedure— Proceed as directed in the chapter.Saturate the chamber with Developing solvent systemfor 2hours.Spray with Spray reagent,and heat in an oven at 105for 10minutes.Immediately examine the plate in white light:the chromatogram of the Test solutionexhibits,among other spots,eight brown-violet spots at the RFvalues of about 0.70,0.60,0.50,0.36,0.30,0.28,0.20,and 0.18,corresponding in color and RFvalues to those obtained in the chromatogram of the Standard solution.
B: Add 2mLof glacial acetic acid to 0.1g of Powdered Extract,warm for 5minutes in a hot water bath,and filter.Gently add 0.5mLof sulfuric acid to 1.0mLof the filtrate:a red-brown color develops at the zone of contact.
C: The retention times of the peaks for ginsenosides Rg1,Re,Rf,Rb1,Rb2,Rc,and Rd in the chromatogram of the Test solutioncorrespond to those in the chromatogram of the Standard solution,as obtained in the test for Content of ginsenosides.The ratio of the peak area of Rb2to the peak area of Rb1is not less than 0.4.
Microbial enumeration á2021ñ— The total aerobic microbial count does not exceed 300cfu per g,and the total combined molds and yeasts count does not exceed 100cfu per g.It meets the requirements of the tests for absence of Salmonellaspecies,Escherichia coli,and Staphylococcus aureus.
Water,Method Iá921ñ: not more than 7.0%,determined on a 0.15-g specimen.
Pesticide residues á561ñ: meets the requirements.
Heavy metals á231ñ: 30µg per g.
Change to read:
Content of ginsenosides—
Diluent— Prepare a mixture of water and alcohol (6:4).
Solution A— Use filtered and degassed water.
Solution B— Prepare a filtered and degassed mixture of acetonitrile and water (8:2).
Mobile phase— Use variable mixtures of Solution Aand Solution Bas directed for Chromatographic system.Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Standard solution— Transfer an accurately weighed amount of USP Powdered Asian Ginseng Extract RSto a suitable volumetric flask,fill the flask with Diluentto about 60%of its nominal volume,dissolve by sonicating for 10minutes,dilute with Diluentto volume to obtain a solution having a known concentration of about 24mg per mL,mix,and filter.
Test solution— Proceed as directed for Standard solution,except to use Powdered Extract.
Chromatographic system (see Chromatography á621ñ)— The liquid chromatograph is equipped with a 203-nm detector,a 4.6-mm ×2.0-cm guard column that contains packing L1,and a 4.6-mm ×15-cm analytical column that contains 3-µmUSP28packing L1.The flow rate is about 1.5mLper minute.The column temperature is maintained at 25.USP28The chromatograph is programmed as follows.
Time
(minutes)		 Solution A
(%)		 Solution B
(%)		 Elution
0 76 24 equilibration
0–12 76 24 isocratic
12–28 76®65 24®35 linear gradient
28–51.5 65®56.5 35®43.5 linear gradient
51.5–52.5 56.5®
0USP28		 43.5®100USP28 linear gradient
52.5–64.5 0®76 100®24 linear gradientUSP28
64.5–77USP28 76 24 isocratic
Chromatograph the Standard solution,and record the peak areas as directed for Procedure:the chromatogram is similar to the Reference Chromatogram provided with the lot of USP Powdered Asian Ginseng Extract RSbeing used;and the relative standard deviation,determined for the sum of the peak areas for the six major ginsenosides,for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 20µL)of the Standard solutionand the Test solutioninto the chromatograph,record the chromatograms,identify the peaks for the ginsenosides by comparison with the Reference Chromatogram provided with the lot of USP Powdered Asian Ginseng Extract RSbeing used,and measure the peak areas for the six major ginsenosides.Calculate the percentage of each relevant ginsenoside (Rg1,Re,Rb1,Rc,Rb2,and Rd)in the portion of Powdered Extract taken by the formula:
(WS/WT)(rU/rS)P,
in which WSis the weight,in mg,of USP Powdered Asian Ginseng Extract RStaken to prepare the Standard solution;WTis the weight,in mg,of Powdered Extract taken to prepare the Test solution;rUand rSare the peak areas for each relevant ginsenoside obtained from the Test solutionand the Standard solution,respectively;and Pis the labeled amount,in percentage,of each relevant ginsenoside in USP Powdered Asian Ginseng Extract RS.Calculate the Content of ginsenosides,in percentage,by adding the percentages of each relevant ginsenoside.
Alcohol content,Method IIá611ñ: not more than 0.25%.
Other requirements— It meets the requirements for Packaging and Storageand for Labelingunder Botanical Extracts á565ñ.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 2099
Pharmacopeial Forum:Volume No.30(2)Page 570
Phone Number:1-301-816-8343