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Powdered American Ginseng Extract
» Powdered American Ginseng Extract is prepared from the pulverized dried roots of Panax quinquefolius L. (Fam. Araliaceae), using suitable solvents, and dried to a powder. It contains not less than 10.0 percent of total ginsenosides, calculated on the anhydrous basis. The ratio of starting crude plant material to Powdered Extract is between 3:1 and 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 565.
Identification—
A: Thin-Layer Chromatographic Identification Test 201—
Test solution: 20 mg 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 Identification test A under American Ginseng.
B: The retention times of the peaks for ginsenosides Rg1, Re, Rb1, Rb2, Rc, and Rd in the chromatogram of the Test solution correspond 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 Rb2 to the peak response for Rb1 is less than 0.4, and the ratio of the peak response for Rg1 to the peak response for Rb1 is less than 0.3. The chromatogram of the Test solution shows 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.
Microbial enumeration 2021— The total aerobic microbial count does not exceed 104 cfu per g; the total combined molds and yeasts count does not exceed 1000 cfu per g; and it meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
Water, Method I 921: not more than 7.0%.
Residue on evaporation 565: meets the requirements.
Pesticide residues 561: meets the requirements.
Alcohol content, Method II 611: not more than 0.25%.
Content of ginsenosides—
Solution A, Solution B, Mobile phase, Standard solution 1, Standard solution 2, and Chromatographic system— Proceed as directed for Content of ginsenosides under American Ginseng.
Test solution— Transfer a quantity of Powdered Extract, equivalent to 5 mg of ginsenosides, accurately weighed, to a suitable container. Dissolve in 10.0 mL of a mixture of water and alcohol (6:4) sonicating for 10 minutes, and filter.
Procedure— Proceed as directed for Content of ginsenosides under American Ginseng. Calculate the percentages of individual ginsenosides in the portion of Powdered Extract taken by the formula:
1000(C/W)(rU / rS),
in which C is the concentration, in mg per mL, of ginsenoside Rg1, Re, Rb1, Rc, Rb2, or Rd in the appropriate Standard solution; W is the weight, in mg, of Powdered Extract taken to prepare the Test solution; and rU and rS are the peak responses of ginsenoside Rg1, Re, Rb1, Rc, Rb2, or Rd obtained from the Test solution and the appropriate Standard solution, respectively. Calculate the percentage of total ginsenosides in the portion of Powdered Extract taken by adding the individual percentages.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Auxiliary Information— Staff Liaison : Maged H. Sharaf, Ph.D., Senior Scientist
Expert Committee : (DSB05) Dietary Supplements - Botanicals
USP29–NF24 Page 2337
Pharmacopeial Forum : Volume No. 30(2) Page 564
Phone Number : 1-301-816-8318