Powdered Echinacea purpurea Extract
» Powdered Echinacea purpurea Extract is prepared from dried Echinacea purpurea Root, Echinacea purpurea Aerial Parts, or a mixture of them, by extraction with hydroalcoholic mixtures or other suitable solvents. The ratio of the starting crude plant material to Powdered Extract is between 2:1 and 8:1. It contains not less than 4.0 percent of total phenols, calculated as the sum of caftaric acid (C13H12O9), chicoric acid (C22H18O12), chlorogenic acid (C16H18O9), and echinacoside (C35H46O20) on the dried basis. It contains not less than 0.025 percent of dodecatetraenoic acid isobutylamides (C16H25NO), calculated on the dried basis.
Packaging and storage
Preserve in tight, light-resistant containers, in a cool place.
Labeling
The label states the Latin binomial and, following the official name, the parts of the plant from which the article was prepared. If derived from root and aerial parts, indicate the corresponding percentages. Label it to indicate the content of total phenols and dodecatetraenoic isobutylamides. The label bears a statement indicating that Echinacea purpurea may cause rare allergic reactions, rashes, or aggravate asthma. It meets the requirements for Labeling under Botanical Extracts 565.
USP Reference standards 11
USP Chlorogenic Acid RS. USP Powdered Echinacea purpurea Extract RS. USP 2E,4E-Hexadienoic Acid Isobutylamide RS .
Identification
A:
Thin-Layer Chromatographic Identification Test 201
Test solution
Weigh and finely pulverize about 10 g of Powdered Extract, and transfer 1 g of the powder to a suitable extraction thimble. Transfer the thimble to a continuous extraction apparatus, and extract with 50 mL of chloroform for 1 hour. Evaporate the chloroform extract to dryness at 40 in vacuum. To the residue, add 1 mL of alcohol, and pass through a nylon membrane filter having a porosity of 0.45 µm.
Standard solution 1
Dissolve an accurately weighed quantity of USP Powdered Echinacea purpurea Extract RS in methanol to obtain a solution having a known concentration of about 100 mg per mL.
Standard solution 2, Developing solvent system, Spray reagent, and Procedure
Proceed as directed for Identification test B under Echinacea angustifolia.
B:
The retention times of the peaks for chicoric and caftaric acids in the chromatogram of the Test solution correspond to those in the chromatogram of Standard solution 1, as obtained in the test for Content of total phenols.
Content of total phenols
Solvent, Solution A, Solution B, Mobile phase, Standard solution 2, and Chromatographic system
Proceed as directed for Content of total phenols under Echinacea angustifolia.
Standard solution 1
Dissolve an accurately weighed quantity of USP Powdered Echinacea purpurea Extract RS in Solvent, shaking for 1 minute, and dilute with Solvent to obtain a solution having a known concentration of about 5 mg per mL. Pass through a membrane filter having a 0.45-µm or finer porosity.
Test solution
Transfer about 60 mg of Powdered Extract, accurately weighed, to a suitable round-bottom flask equipped with a condenser. Add 25 mL of Solvent, and heat under reflux while shaking by mechanical means for 15 minutes. Centrifuge, or pass through a membrane filter having a 0.45-µm or finer porosity.
Procedure
Proceed as directed in the test for Content of total phenols under Echinacea purpurea Root. Calculate the percentage of each relevant component of total phenols in the portion of Powdered Extract taken by the formula:
2500F(C/W)(ri / rS)
in which F is the response factor and is equal to 0.695 for chicoric acid, 0.881 for caftaric acid, 1.000 for chlorogenic acid, and 2.220 for echinacoside; C is the concentration, in mg per mL, of USP Chlorogenic Acid RS in Standard solution 2; W is the weight, in mg, of the portion of Powdered Extract taken; ri and rS are the peak responses for the relevant analyte obtained from the Test solution and Standard solution 2, respectively. Calculate the percentage of total phenols in the portion of Powdered Extract taken by adding the individual percentages.
Content of dodecatetraenoic acid isobutylamides
Mobile phase and Standard solution 2
Proceed as directed for Content of dodecatetraenoic acid isobutylamides under Echinacea angustifolia.
Standard solution 1
Proceed as directed for Content of dodecatetraenoic acid isobutylamides under Echinacea angustifolia, except to use USP Powdered Echinacea purpurea Extract RS instead of USP Powdered Echinacea angustifolia Extract RS.
Test solution
Proceed as directed for Content of dodecatetraenoic acid isobutylamides under Echinacea angustifolia, except to use Powdered Echinacea purpurea Extract instead of Powdered Echinacea angustifolia Extract.
Chromatographic system
Proceed as directed for Content of dodecatetraenoic acid isobutylamides under Echinacea angustifolia, except to use the Reference Chromatogram for alkamides provided with USP Powdered Echinacea purpurea Extract RS instead of the Reference Chromatogram provided with USP Powdered Echinacea angustifolia Extract RS.
Procedure
Proceed as directed in the test for Content of dodecatetraenoic acid isobutylamides under Echinacea angustifolia. Calculate the percentage of dodecatetraenoic acid isobutylamides in the portion of Powdered Extract taken by the formula:
10(1.353)(C/W)(ri / rS)
in which 1.353 is the response factor for 2E,4E-hexadienoic acid isobutylamide; C is the concentration, in mg per mL, of USP 2E,4E-Hexadienoic Acid Isobutylamide RS in Standard solution 2; W is the weight, in g, of the portion of Powdered Extract taken; ri is the sum of the peak responses of the relevant analytes obtained from the Test solution; and rS is the peak response obtained from Standard solution 2.
Other requirements
It meets the requirements for Microbial enumeration, Loss on drying, Heavy metals, and Organic volatile impurities under Powdered Echinacea angustifolia Extract, and it meets the requirements for Residual Solvents and Pesticide Residues under Botanical Extracts 565.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
Chromatographic Column
USP32NF27 Page 1001
Pharmacopeial Forum: Volume No. 30(2) Page 561
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
|