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 parts of the plant contained in the article.

USP Reference standards 11— USP Berberine Chloride RS. USP Hydrastine Hydrochloride RS.

Botanic characteristics— The powder is dark yellow to moderately greenish yellow with an aromatic odor and bitter taste. Abundant starch granules are present and are either spherical or ovoid; the granules are simple or compounded, with an occasional slit-shaped hilum. Parenchyma cells range from polygonal to round and are filled with starch or brown resin. Tracheary elements with slit-shaped pits and a few large reticulated vessels are present, as are beaded, thick-walled elongated epidermal cells. Thin fragments of cork layer are also present.

Other requirements— It meets the requirements of the Thin-layer chromatographic identification test and the tests for Loss on drying, Foreign organic matter, Total ash, Acid-insoluble ash, Pesticide residues, Heavy metals, and Content of berberine and hydrastine and limit of palmatine under Goldenseal.

Expert Committee : (DSB05) Dietary Supplements - Botanicals

USP29–NF24 Page 2345

Phone Number : 1-301-816-8318