Powdered Licorice Extract
»Powdered Licorice Extract is prepared from comminuted Licorice extracted with water or suitable solvents such as alcohol,water,or mixtures of these solvents.The ratio of the crude plant material to Powdered Extract is between 5:1and 7:1.It contains not less than 6.0percent of glycyrrhizic acid (C42H62O16),calculated on the dried basis.
Packaging and storage— Preserve in tight containers,protected from light.
Change to read:
Labeling— The label states the Latin binomial and,following the official name,the part of the plant from which the article was derived.The label also indicates the content of glycyrrhizic acid,the extracting solvent or solvent mixture used for preparation,and the ratio of the starting material to final product.The label bears a statement indicating that “Excessive amounts or long-term use of Licorice may cause high blood pressure or low potassium,which have been associated with irregular heartbeat and/or muscle weakness.Licorice may worsen the effects of congestive heart failure,cirrhosis,or kidney failure.Diuretic use may increase the risk.If you are pregnant or nursing a baby,seek the advice of a health professional before using this product.”USP28It meets the requirements for Labelingunder Botanical Extracts á565ñ.
Thin-layer chromatographic identification test á201ñ—
Standard solution,Application volume,Developing solvent system,andProcedure— Proceed as directed for Thin-layer chromatographic identification testunder Licorice.
Test solution— Dissolve about 0.6g of Powdered Extract,accurately weighed,in 10mLof a mixture of alcohol and water (1:1).
Loss on drying á731ñ— Dry it at 105for 6hours:it loses not more than 10.0%of its weight.
Total ash á561ñ: not more than 12.0%.
Pesticide residues á561ñ: meets the requirements.
Content of glycyrrhizic acid—
Solvent,Mobile phase,Standard solution,andChromatographic system— Proceed as directed for Content of glycyrrhizic acidunder Licorice.
Test solution— Transfer about 150mg of Powdered Extract,accurately weighed,to a suitable flask,add 25mLof Solvent,heat at 50for 30minutes,cool,centrifuge,and decant the supernatant into a 100-mLvolumetric flask.Mix the residue with 20mLof Solvent,repeat the above procedure,and dilute with Solventto volume.
Procedure— Proceed as directed for Content of glycyrrhizic acidunder Licorice,except to calculate the percentage of glycyrrhizic acid (C42H62O16)in the portion of Powdered Extract taken by the formula:
10,000(C/W)(rU/rS),
in which Wis the weight,in mg,of the Powdered Extract taken to prepare the Test solution;and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 2109
Pharmacopeial Forum:Volume No.30(2)Page 574
Phone Number:1-301-816-8343