Powdered Goldenseal Extract
»Powdered Goldenseal Extract is prepared from the pulverized dried roots and rhizomes of Hydrastis canadensis(L.)(Fam.Ranunculaceae)using suitable solvents.It contains not less than 5percent of hydrastine (C21H21NO6)and not less than 10percent of total alkaloids.The ratio of starting crude plant material to Powdered Extract is 2:1.
Packaging and storage— Store in tight containers,protected from light and moisture.
Labeling— The label states the Latin binomial and,following the official name,the part of the plant from which the article was prepared.Label it to indicate the content of hydrastine and berberine,the extracting solvent used for preparation,and the ratio of the starting crude plant material to Powdered Extract.
USP Reference standards á11ñ— USP Berberine Chloride RS.USP Hydrastine Hydrochloride RS.
Thin-layer chromatographic identification test á201ñ—
Test solution— Transfer about 100mg of Powdered Extract,accurately weighed,to a 10-mLvolumetric flask,and dilute with a mixture of methanol and water (1:1)to volume.Sonicate for 20minutes,cool to room temperature,mix,and filter.
Standard solution,Application volume,Developing solvent system,and Procedure— Proceed as directed for Thin-layer chromatographic identification testunder Goldenseal.
Microbial enumeration á2021ñ— The total aerobic microbial count does not exceed 104cfu per g and the total combined molds and yeasts count does not exceed 103cfu per g.It meets the requirements of the tests for absence of Salmonellaspecies and Escherichia coli.
Loss on drying á731ñ— Dry about 1.0g of Powdered Extract,accurately weighed,at 105for 2hours:it loses not more than 5.0%of its weight.
Pesticide residues á561ñ: meets the requirements.
Heavy metals,Method IIá231ñ: not more than 20µg per g.
Content of total alkaloids—
Mobile phase,Standard solution,and Chromatographic system— Proceed as directed for Content of berberine and hydrastineunder Goldenseal.
Test solution— Transfer about 100mg of Powdered Extract,accurately weighed,to a 50-mLvolumetric flask,and dilute with a mixture of water and methanol (1:1).Sonicate for 20minutes,cool to room temperature,mix,and filter.
Procedure— Proceed as directed for Content of berberine and hydrastineunder Goldenseal,except to calculate the percentages of hydrastine and berberine in the portion of Powdered Extract taken by the formula:
100(C/R)(V/W)(rU/rS),
in which Ris the fraction of the test sample left after undergoing the test for Loss on drying(see NOTEbelow);Wis the weight,in mg,of Powdered Extract taken for the Test solution;and the other terms are as defined therein:not less than 5%of hydrastine is found;and not less than 10%of hydrastine plus berberine is found.[NOTE—Ris defined as the residue,in g,from the test for Loss on dryingdivided by the quantity,in g,of the original sample undergoing the test for Loss on drying.The sample to be used in the test for Content of total alkaloidsshould not be subjected to the conditions specified in the test for Loss on drying.Aseparate sample is used to determine the value of R.]
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 2104
Pharmacopeial Forum:Volume No.30(3)Page 954
Phone Number:1-301-816-8343
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