Powdered Horse Chestnut Extract
»Powdered Horse Chestnut Extract is prepared from Horse Chestnut by extraction with alcohol–water mixtures or methanol–water mixtures.The ratio of starting plant material to extract is between 5:1and 8:1.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of triterpene glycosides,calculated on the dried basis as escin (C55H86O24).It may contain suitable added substances.
Packaging and storage— Preserve in tight,light-resistant containers.Store in a cool place.
Labeling— The label states the Latin binomial and,following the official name,the part of the plant from which the article was prepared.The label also indicates the content of triterpene glycosides,the extracting solvent or solvent mixture used for preparation,the ratio of the starting crude plant material to Powdered Extract,and the name and content of any added substance.It meets the requirements for labeling under Botanical Extracts á565ñ.
Thin-layer chromatographic identification test á201ñ—
Standard solution,Developing solvent system,and Procedure— Proceed as directed for Thin-layer chromatographic identification test á201ñunder Horse Chestnut.
Test solution— To 10mLof methanol,add a quantity of Powdered Extract equivalent to 25mg of the labeled amount of triterpene glycosides,and shake.Allow to stand for 15minutes before use.
Microbial enumeration á2021ñ— It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.The total aerobic microbial count does not exceed 104cfu per g,the total combined molds and yeasts count does not exceed 100cfu per g,and the count for enterobacteria does not exceed 1000cfu per g.
Change to read:
Loss on drying á731ñ: Dry 1g at 105for 2hours.It losesUSP28not more than 5.0%.
Heavy metals,Method IIá231ñ: not more than 20µg per g.
Content of triterpene glycosides—
Solvent 1,Solvent 2,Reagent,and Escin standard solutions— Proceed as directed forContent of triterpene glycosidesunderHorse Chestnut.
Test solution— Transfer an accurately weighed quantity of Powdered Extract,equivalent to about 50mg of the labeled content of triterpene glycosides,into a 50-mLflask.Add 20mLof 0.1Nhydrochloric acid,and shake for 5minutes.Filter into a 250-mLseparatory funnel with the aid of two additional 5-mLportions of 0.1Nhydrochloric acid.Proceed as directed forTest solution in the test forContent of triterpene glycosides underHorse Chestnut,starting with “Add 20mLof 1-propanol and 50mLof chloroform.”
Procedure— Proceed as directed forProcedure in the test forContent of triterpene glycosides underHorse Chestnut.Calculate the percentage of triterpene glycosides in the portion of Powdered Extract taken by the formula:
5000(C/W),
in which Cis the concentration,in mg per mL,of triterpene glycosides in theTest solution as obtained above;and Wis the weight,in mg,of Powdered Extract taken to prepare theTest solution.
Other requirements— It meets the requirements forPackaging and Storage,Residual Solvents,and Pesticide Residuesunder General Pharmacopeial Requirementsfor powdered extracts underBotanical Extracts á565ñ.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 2108
Pharmacopeial Forum:Volume No.30(2)Page 550
Phone Number:1-301-816-8343