Powdered American Ginseng Extract
»Powdered American Ginseng Extract is prepared from the pulverized dried roots of Panax quinquefoliusL.(Fam.Araliaceae),using suitable solvents,and dried to a powder.It contains not less than 10.0percent of total ginsenosides,calculated on the anhydrous basis.The ratio of starting crude plant material to Powdered Extract is between 3:1and 7:1.
Packaging and storage— Preserve in tight,light-resistant containers.
Labeling— The label states the Latin binomial and,following the official name,the part of the plant from which the article was derived.Label it to indicate the content of total ginsenosides,the extracting solvent used for preparation,and the ratio of the starting crude plant material to the Powdered Extract.It meets the labeling requirements under Botanical Extracts á565ñ.
Identification—
A: Thin-Layer Chromatographic Identification Test á201ñ—
Test solution: 20mg per mL,in methanol.
Standard solution 1,Standard solution 2,Application volume,Developing solvent system 1,Developing solvent system 2,Spray reagent,and Procedure— Proceed as directed for Identificationtest Aunder American Ginseng.
B: The retention times of the peaks for ginsenosides Rg1,Re,Rb1,Rb2,Rc,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 ginsenosides.The ratio of the peak response 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 of the Test solutionshows no significant peak at the retention time corresponding to that for ginsenoside Rf in the chromatogram of Standard solution 2,as obtained in the test for Content of ginsenosides.
Change to read:
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;and it meets the requirements of the tests for absence of Salmonellaspecies and Escherichia coli.USP28
Water,Method Iá921ñ: not more than 7.0%.
Residue on evaporation á565ñ: meets the requirements.
Pesticide residues á561ñ: meets the requirements.
Alcohol content,Method IIá611ñ: not more than 0.25%.
Change to read:
Content of ginsenosides—
Solution A,Solution B,Mobile phase,Standard solution 1,Standard solution 2,and Chromatographic system— Proceed as directed for Content of ginsenosidesunder American Ginseng.
Test solution— Transfer a quantityUSP28of Powdered Extract,equivalent to 5mg of ginsenosides,USP28accurately weighed,to a suitable container.Dissolve in 10.0mLof a mixture of water and alcohol (6:4)sonicating for 10minutes,and filter.USP28
Procedure— Proceed as directed for Content of ginsenosidesunder American Ginseng.Calculate the percentages of individual ginsenosides in the portion of Powdered Extract taken by the formula:
1000(C/W)(rU/rS),USP28
in which Cis the concentration,in mg per mL,of ginsenoside Rg1,Re,Rb1,Rc,Rb2,or Rd in the appropriate Standard solution;Wis the weight,in mg,of Powdered Extract taken to prepare the Test solution;and rUand rSare the peak responses of ginsenoside Rg1,Re,Rb1,Rc,Rb2,or Rd obtained from the Test solutionand the appropriate Standard solution,respectively.Calculate the percentage of total ginsenosides in the portion of Powdered Extract taken by adding the individual percentages.
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 564
Phone Number:1-301-816-8343