Powdered Horse Chestnut Extract
» Powdered Horse Chestnut Extract is prepared from Horse Chestnut by extraction with alcoholwater mixtures or methanolwater mixtures. The ratio of starting plant material to extract is between 5:1 and 8:1. It contains not less than 90.0 percent and not more than 110.0 percent 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 565.
Thin-layer chromatographic identification test 201
Standard solution, Developing solvent system, and Procedure Proceed as directed for Thin-layer chromatographic identification test 201 under Horse Chestnut.
Test solution To 10 mL of methanol, add a quantity of Powdered Extract equivalent to 25 mg of the labeled amount of triterpene glycosides, and shake. Allow to stand for 15 minutes before use.
Microbial enumeration 2021 It meets the requirements of the tests for absence of Salmonella species and Escherichia coli. The total aerobic microbial count does not exceed 104 cfu per g, the total combined molds and yeasts count does not exceed 100 cfu per g, and the count for enterobacteria does not exceed 1000 cfu per g.
Loss on drying 731: Dry 1 g at 105 for 2 hours. It loses not more than 5.0%.
Heavy metals, Method II 231: not more than 20 µg per g.
Content of triterpene glycosides
Solvent 1, Solvent 2, Reagent, and Escin standard solutions Proceed as directed for Content of triterpene glycosides under Horse Chestnut.
Test solution Transfer an accurately weighed quantity of Powdered Extract, equivalent to about 50 mg of the labeled content of triterpene glycosides, into a 50-mL flask. Add 20 mL of 0.1 N hydrochloric acid, and shake for 5 minutes. Filter into a 250-mL separatory funnel with the aid of two additional 5-mL portions of 0.1 N hydrochloric acid. Proceed as directed for Test solution in the test for Content of triterpene glycosides under Horse Chestnut, starting with Add 20 mL of 1-propanol and 50 mL of chloroform.
Procedure Proceed as directed for Procedure in the test for Content of triterpene glycosides under Horse Chestnut. Calculate the percentage of triterpene glycosides in the portion of Powdered Extract taken by the formula:
5000(C/W)in which C is the concentration, in mg per mL, of triterpene glycosides in the Test solution as obtained above; and W is the weight, in mg, of Powdered Extract taken to prepare the Test solution.
Other requirements It meets the requirements for Packaging and Storage, Residual Solvents, and Pesticide Residues under General Pharmacopeial Requirements for powdered extracts under Botanical Extracts 565.
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 1040Pharmacopeial Forum: Volume No. 30(2) Page 550