U.S. PHARMACOPEIA

Search USP29  
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 5 percent of hydrastine (C21H21NO6) and not less than 10 percent of the sum of berberine and hydrastine, calculated on the dried basis. The ratio of starting crude plant material to Powdered Extract is 2:1.
Packaging and storage— Preserve 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 11— USP Berberine Chloride RS. USP Hydrastine Hydrochloride RS.
Thin-layer chromatographic identification test 201—
Test solution— Transfer about 100 mg of Powdered Extract, accurately weighed, to a 10-mL volumetric flask, and dilute with a mixture of methanol and water (1:1) to volume. Sonicate for 20 minutes, cool to room temperature, mix, and filter.
Standard solution, Application volume, Developing solvent system, and Procedure— Proceed as directed for Thin-layer chromatographic identification test under Goldenseal.
Microbial enumeration 2021— The total aerobic microbial count does not exceed 104 cfu per g and the total combined molds and yeasts count does not exceed 103 cfu per g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
Loss on drying 731— Dry about 1.0 g of Powdered Extract, accurately weighed, at 105 for 2 hours: it loses not more than 5.0% of its weight.
Pesticide residues 561: meets the requirements.
Heavy metals, Method II 231: not more than 20 µg per g.
Content of berberine and hydrastine and limit of palmatine—
Mobile phase, Standard solution, and Chromatographic system— Proceed as directed for Content of berberine and hydrastine and limit of palmatine under Goldenseal.
Test solution— Transfer about 100 mg of Powdered Extract, accurately weighed, to a 50-mL volumetric flask, and dilute with a mixture of water and methanol (1:1). Sonicate for 20 minutes, cool to room temperature, mix, and filter.
Procedure— Proceed as directed for Content of berberine and hydrastine and limit of palmatine under Goldenseal, except to calculate the percentages of hydrastine and berberine in the portion of Powdered Extract taken by the formula:
100C(V/W)(rU / rS),
in which W is 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. Using the values obtained from the chromatogram of the Test solution, divide the peak area of berberine by the peak area of any peak at the locus for palmatine (if present): the ratio is more than 50:1. [NOTE— The sample to be used in this test should not be subjected to the conditions specified in the test for Loss on drying. A separate sample is used to determine the content on the dried basis.]
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 2345
Pharmacopeial Forum : Volume No. 30(3) Page 954
Phone Number : 1-301-816-8318